April 15, 1998 98-15 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Acidified foods packaged in glass jars under the Goodies Delight label: a) Bread N' Butter Pickles, 8 oz. jar b) Chow Chow, 8 oz. jar c) Candied Cucumber Rings, 8 oz. jar d) Corn Relish, 16 oz. jar e) Golden Glow Pickles, 8 oz. jar f) Hot Pepper Jelly, 16 oz. jar g) Jalapeno Peppers, 32 oz. jar h) Mustard Dill Pickles, 8 oz. jar I) Pickled Okra, 8 oz. jar j) Pickled Watermelon Rinds, 8 oz. jar k) Ripe Tomato Pickles, 32 oz. jar l) Squash Delight, 16 oz. jar m) Sweet Pickles, 32 oz. jar n) Sweet N' Sour Zucchini Pickles, 32 oz. jar o) Zucchini Bread N' Butter Pickles, 16 oz. jar p) Zucchini Relish, 32 oz. jar q) Zucchini Sweet Pickles, 16 oz. jar Recall #F-340/356-8. CODE None. MANUFACTURER Goodies Delight, Whitesville, North Carolina. RECALLED BY Manufacturer, by telephone on March 11, 1998. Ongoing recall resulted from sample analysis and follow-up by the North Carolina Department of Agriculture. DISTRIBUTION South Carolina, North Carolina. QUANTITY 20 12-pint jar cases (240 jars) were distributed. REASON The products had been manufactured and processed without the firm keeping mandatory manufacturing records or filing its scheduled process for each product. _______________ PRODUCT Chicken Gravy Mix in 1 oz. Packages and Country Gravy Mix in 1.25 oz. Packages: a) Chicken Gravy Mix, under the private labels Sauce Classics, distributed by Han-Dee Pak, Inc., Cockeysville, Maryland and Hill Country Fare, distributed by H-E-B, San Antonio, Texas b) Country Gravy Mix, under the private labels Our Family, distributed by Nash Finch Company, Minneapolis, Minnesota and Spartan, distributed by Spartan Stores, Inc., Grand Rapids, Michigan. Recall #F-443/444-8. CODE Date Code: 2361AH (Sauce Classics Chicken Gravy only) and 2361BH. MANUFACTURER Ampacco, Inc., Hunt Valley, Maryland. RECALLED BY Manufacturer, by letter on March 17, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 324 cartons (24 packages/carton) of Our Family Country Gravy was produced and distributed; 604 cartons of Spartan Country Gravy Mix were produced and distributed; 124 cartons of Hill Country Fare Chicken Gravy Mix were produced and distributed; 600 cartons of Sauce Classics Chicken Gravy Mix were produced and distributed. REASON The Chicken Gravy Mix contains undeclared certified colors (FD&C Yellow No. 5 & 6,) and lactose. The Country Gravy Mix contains undeclared milk. _______________ PRODUCT Cake Mix - individual units are in boxes labeled as "Duncan Hines White Cake Mix", shipping cartons are labeled as "Duncan Hines Princess White Cake Mix". Recall #F-445-8. CODE 8028E2. MANUFACTURER Procter and Gamble Company, Jackson, Tennessee. RECALLED BY Aurora Foods, Inc., Columbus, Ohio, by press release on March 26, 1998, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Canada. QUANTITY 6,909 cases (82,908 total retail packages) were distributed; firm estimated that 4,622 cases (55,464 retail packages) remained on market at time of recall initiation. REASON Product contains undeclared soy protein. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========== _______________ PRODUCT Dobutamine in 5% Dextrose Injection, 500 mg (2000 mcg/mL), in 250 mL flexible containers with foil overwrap, Rx intravenous solution for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. NDC #0074-2347-32. Recall #D-113-8. CODE 28-488-DR, 28-490-DR, 28-491-DR, 29-497-DR. MANUFACTURER Abbott Laboratories, North Chicago, Illinois. RECALLED BY Manufacturer, by letter dated March 20, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and The Netherlands. QUANTITY 29,952 units were distributed; firm estimated that 3,000 units remained on market at time of recall initiation. REASON Mislabeling -- Some correctly labeled 500 mg units are over wrapped with an incorrect 250 mg foil labeled pouch. _______________ PRODUCT Estraderm (Estradiol Transdermal System), 0.1 mg/day, one patch per pouch (8 mg Estradiol USP) with 8 pouches per carton sold in boxes of 6, a patch system therapy for estrogen replacement in post menopausal women. NDC #0083-2320-62. Recall #D-114-8. CODE Lot #1F210345 EXP 11/98. MANUFACTURER Novartis Pharmaceuticals Corporation (formerly Ciba-Geigy), Suffern, New York. RECALLED BY Manufacturer, by letters by fax on March 19, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 26,012 packers (each packer contain 6 cartons of 8 systems/individual units) were distributed. REASON Content uniformity failure - Superpotent. _______________ UPDATE Inwood Laboratories (Inwood, New York), Propranolol HCL, Recall #D-100/103-8, which appeared in the April 1, 1998, Enforcement Report has been extended to include 61 additional lot numbers: *** Additional 23 lots of 60 mg: 6K044 (4/98), 6K045 (4/98), 6L001 (4/98), 6L002 (4/98),6L003 (4/98), 6L004 (4/98), 6L005 (4/98), 6L006 (4/98), 6M033 (4/98), 6M036 (4/98), 6M035 (5/98), 6M037 (5/98), 6M038 (5/98), 7A062 (6/98), 7A065 (6/98), 7B004 (6/98), 7B005 (6/98), 7B006 (6/98), 7B007 (6/98), 7B008 (6/98), 7B022 (8/98), 7B025 (7/98) & 7D010 (11/98). *** Additional 12 lots of 80 mg: 6H012 (7/98), 6J098 (8/98), 6J099 (9/98), 6K020 (9/98), 6K021 (10/98), 6K022 (11/98), 7A045 (12/98), 7A046 (1/99), 7A047 (1/99), 7C023 (2/99), 7D013 (3/99) & 7C025 (3/99). *** Additional 11 lots of 120 mg: 6J100 (8/98), 6J101 (9/98), 6K023 (9/98), 6K024 (10/98), 6K025 (10/98), 6K026 (11/98), 7A050 (11/98), 7A051 (12/98), 7A052 (11/99), 7A053 (1/99) & 7C027 (2/99). *** Additional 15 lots of 160 mg: 6H018 (8/98), 6H028 (8/98), 6J102 (8/98), 6J103 (8/98), 6K029 (10/98), 6K031 (10/98), 6K032 (10/98), 7A054 (11/98),7A055 (11/98), 7A056 (12/98), 7A057 (1/99), 7A058 (1/99), 7C031 (2/99), 7C032 (3/99) & 7F059 (5/99). RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Vicodin Tablets (Hydrocodone Bitartrate 5 mg/Acetaminophen 500 mg), 25 tablets in individual foil packets (1 per packet), intended for the treatment of moderate to severe pain and was shipped as physician samples. NDC #0044-0727-91. Recall #D-112-8. CODE Lot #10760535 EXP 10/98. MANUFACTURER Knoll Pharmaceutical Company, Mount Olive, New Jersey. RECALLED BY Knoll Pharmaceutical Company, Whippany, New Jersey (responsible firm), by letter on December 2, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 54,831 cartons (1,370,775 tablets) were distributed. REASON Dissolution failure -(acetaminophen-21 month stability). _______________ PRODUCT Oxygen USP Compressed, in high pressure "E" cylinders. Recall #D-115-8. CODE Lot numbers: A03H350A, A03H350B, A03H350C A03H350D, A03H350E, A04H352A, A04H352B A04H352C, A04H352D, A04H352E, A04H352F And other lots of unknown coding. MANUFACTURER G.S. Parsons, doing business as Parsons Airgas, San Diego, California. RECALLED BY Manufacturer, by letter dated March 24, 1998. Firm-initiated recall ongoing. DISTRIBUTION California. QUANTITY 80 cylinders were distributed. REASON Misbranding - Some empty cylinders were re-distributed. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Red Blood Cells. Recall #B-283-8. CODE 40GN69533. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on August 21, 1997, and by letter dated September 15, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor whose suitability was not adequately determined. _______________ PRODUCT Red Blood Cells. Recall #B-513-8. CODE 0392610, 0392619, 0393187, 5237334, 5212148, 5227359, 0392399, 0392423, 0392424, 5215759, 5227768, 5237362. MANUFACTURER Blood Systems Laboratories, Tempe, Arizona (testing facility). RECALLED BY New York Blood Center, Inc., New York, New York, by letter dated December 31, 1997. Firm-initiated recall ongoing. DISTRIBUTION New York and New Jersey. QUANTITY 12 units were distributed. REASON Blood products were mislabeled for the Rh(D) antigen because of failure to follow accepted testing standards for the determination of the Rh(D) type. _______________ PRODUCT Baxter Fenwal Plasmacell-C Disposable Sets, consisting of the separation device, a reservoir and a tubing set which provides transport for the blood and solutions within a closed blood pathway when used with the Fenwal Autopheresis-C Plasmapheresis System: a) 4R2252, Plasmacell-C Separation Disposable Set, 60 units per case b) 4R2256, Plasmacell-C Separation Disposable Set, for use with SpikeSmart System, 60 units per case European distribution: c) 4R2250, Plasmacell-C Separation Disposable Set with In-line Anticoagulant Drip Chamber, 60 units per case d) D4R2251, Plasmacell-C Separation Disposable Set with Attached 1000 mL Plasma Collection Bag-French label e) R4R2252, Plasmacell-C Disposable Set - multiple language label f) 4R2262, Plateletcell Disposable Set with Preattached Filter and D4R2262 - French label h) E4R2266, Plasmacell-C TPS Disposable Set for Therapeutic Plasmapheresis I) D4R2278, Plasmacell-C Separation Disposable Set with Pre-Connected Filters (0.22 microns), Needle and Collection Bags - French label and R4R2278 - multiple language label Japanese distribution: j) J4R2252 and J4R2253, Plasmacell-C Separation Disposable Sets - Japanese label k) J4R2283 and J4R2284 - Plasmacell-C Disposable Sets used with the Mini Autopheresis-C with different membranes - Japanese label. Recall #B-738-8. CODE a) 4R2252, lots A97L22103, A97L30114, A98A08053, A98A08061, A98A09044, A98A09069, A98A14093, A98A14101, A98A14119, A98A15074, A98A15108, A98A16098, A98A16106A, A98A21080, A98A23078, A98A23094, A98A26089, A98A28093, A98B02070, A98B02096, A98B04100, A98B04118, A98B06055, A98B10099, A98B10115, A98B12095 b) 4R2256, lots A97L26070, A97L27086, A97L29082, A97L29108, A97L30098, A98A12089, A98A12105, A98A12170, A98A13046, A98A13095, A98A19084, A98A19092, A98A20082, A98A20090, A98A22062, A98A22138, A98A24068, A98A27079, A98A27103, A98A29109, A98A30065, A98A30073, A98A31071, A98B03078 c) 4R2250, lots A98A23060, A98A28069, A98B02054 d) D4R2251, lot A97L29041 e) R4R2252, lots A97L26088, A98A28119, A98A28127, A98A29083 f) 4R2262, lots A98A22120, A98A26071, A98A28077, A98A29067; D4R2262, lots A98A29059, A98B06071 g) 4R2264, lot A98B04068 h) E4R2266, lot A98A08079, A98A09077, A98A12071, A98A12097, A98A13111, A98A14085, A98A15090, A98B09083 I) D4R2278, lot A97L27045; R4R2278, lots A97L22046, A97L26054, A98A22047, A98A29075, A98A31048 j) J4R2252, lots A98A14069, A98A16031, A98A19076, A98A21098, A98A22088, A98A23086, A98A24076, A98B03086, A98B04084; J4R2253, lots A98A27061, A98B02062 k) J4R2283, lot A97L29090; J4R2284, lot A97L30080. MANUFACTURER Baxter S.A. Fenwal Division, Parque Industrial Itabo, Zona Franca Industrial de Haina, San Cristobal, Republica Dominicana RECALLED BY Baxter Healthcare Corporation, Biotech Group/Fenwal Division, Deerfield, Illinois, by letter dated March 3, 1998. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 913,269 sets were distributed in the U.S., 75,382 sets were distributed in Europe, and 11,184 sets were distributed in Japan, with the firm estimating that 1,000,000 sets remain on the market. REASON Manufacturing deviations in the diameter of the anticoagulant line tubing of the Plasmacell-C Disposable sets which cause an increase in anticoagulant flow rate may result in the potential for donor air embolus. _______________ PRODUCT Source Plasma. Recall #B-782-8. CODE Unit numbers: 1551AX and 1725AX. MANUFACTURER Bloomington Plasma, Inc., Bloomington, Illinois. RECALLED BY Manufacturer, by fax on February 9, 1998. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 2 units were distributed. REASON Blood product was collected from an unsuitable donor. _______________ PRODUCT Platelets, Pheresis. Recall #B-783-8. CODE Unit #C99066. MANUFACTURER Regional Health Resources Center, Community Blood Services of Illinois, Urbana, Illinois. RECALLED BY Manufacturer, by telephone on January 5, 1997, and by letter dated January 19, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Recovered Plasma. Recall #B-784-8. CODE Unit numbers: 40FG12263, 40FG14323, 40FG13784. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, on October 24, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 3 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, and was subjected to additional retesting. _______________ PRODUCT Red Blood Cells. Recall #B-785-8. CODE Unit #38FC30422. MANUFACTURER American Red Cross Great Lakes Region, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on January 12, 1998. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product tested negative for CMV but was collected from a donor who previously tested CMV positive. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-819/821-8. CODE Unit numbers: a) KG24037, KN46753 b) KG24037, KN46753; c) KN46753. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated March 9, 1998. Firm-initiated recall ongoing. DISTRIBUTION Louisiana and Virginia. QUANTITY a) 2 units; b) 2 units; c) 1 unit was distributed. REASON Blood products tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was previously repeatedly reactive for anti-HBc on two separate donations. _______________ PRODUCT Source Leukocytes for Further Manufacture. Recall #B-822-8. CODE Unit #3226920. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by telephone and fax on September 30, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who previously tested PKTP repeat reactive and MHA-TP positive, RPR nonreactive for syphilis. _______________ PRODUCT Red Blood Cells. Recall #B-823-8. CODE Unit #40GN68651. MANUFACTURER American Red Cross, Heart of America Region, Peoria, Illinois. RECALLED BY Manufacturer, by letter dated February 19, 1998. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who lived in a malarial endemic area. _______________ PRODUCT Red Blood Cells. Recall #B-824-8. CODE Unit #40LH13022. MANUFACTURER American Red Cross, Heart of America Region, Peoria, Illinois. RECALLED BY Manufacturer, by letter dated March 5, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who lived in a malarial endemic area. _______________ PRODUCT Platelets. Recall #B-841-8. CODE Unit #18E96029. MANUFACTURER American Red Cross, Great Lakes Region, Lansing, Michigan. RECALLED BY Manufacturer, by letter on May 6, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted Red Blood Cells. _______________ PRODUCT Platelets. Recall #B-842-8. CODE Unit #L69635. MANUFACTURER South Bend Medical Foundation, South Bend, Indiana. RECALLED BY Manufacturer, by telephone on November 17, 1997. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-858/859-8. CODE Unit numbers: a) 38FC27919; b) 38P47427, 38P47503. MANUFACTURER American Red Cross Great Lakes Regional, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated September 24, 1997. Firm-initiated recall complete. DISTRIBUTION Alabama, Indiana, Ohio. QUANTITY a) 1 unit; b) 2 units were distributed. REASON Blood products tested negative for CMV, but were collected from a donor who previously tested CMV positive. _______________ PRODUCT Red Blood Cells. Recall #B-866-8. CODE Unit #29FL48234. MANUFACTURER The American Red Cross, Mid-Atlantic Region, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated January 12, 1998. Firm-initiated recall complete. DISTRIBUTION Virginia and Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Cryoprecipitate AHF; c) Plasma, Cryoreduced; d) Recovered Plasma, Frozen. Recall #B-872/875-8. CODE Unit numbers: a) 29GT81176, 29GT65483, 29GT59170; b) 29GT59170; c) 29GT59170 d) 29GT81176, 29GT65483. MANUFACTURER The American Red Cross, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated February 24, 1998. Firm-initiated recall complete. DISTRIBUTION California, North Carolina, Virginia. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 2 units were distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ UPDATE Recovered Plasma, Unit #13FJ26037, should have been listed in the April 8, 1998, Enforcement Report as Recall #B-853-8. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Whole Blood for Reagent Use. Recall #B-710-8. CODE Unit #3044. MANUFACTURER Blood and Plasma Research, Inc., Beaumont, Texas. RECALLED BY Manufacturer, by telephone and by letter dated December 11, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was tested for the HIV-1 p24 antigen using a sample that remained at an unmonitored temperature for an unknown period of time during shipment. _______________ PRODUCT Cryoprecipitated AHF. Recall #B-765-8. CODE Unit #40FL17972. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on November 10, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. _______________ PRODUCT Red Blood Cells. Recall #B-817-8. CODE Unit numbers: 39Z20468, 39E26713, 39F63596, 39E26727. MANUFACTURER American Red Cross Blood Services, Huntington, West Virginia. RECALLED BY Manufacturer, by telephone on January 23, 1998. Firm-initiated recall complete. DISTRIBUTION West Virginia. QUANTITY 4 units were distributed. REASON Blood products, for which the temperature at the time of receipt was not documented _______________ PRODUCT Recovered Plasma, for Manufacture of Non-Injectables. Recall #B-867-8. CODE Unit #29FL48234. MANUFACTURER The American Red Cross, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated January 12, 1998, and February 11, 1998. Firm-initiated recall complete. DISTRIBUTION Virginia and Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT HPC-93 Collimator component of the Head of a Gamma Camera. The collimator itself is a heavy metal barrier with fixed holes. It is designed to allow only the gamma radiation from the part of the body being examined to reach the gamma camera and acts as a nuclear lenses. The collimators also provide thermal and physical protection for the scintillation crystals of the gamma camera. Recall #Z-486-8. CODE Various non-sequential serial numbers and tag I.D.'s. MANUFACTURER Elscint, Ltd., Advanced Technology Center, Haifa, Israel. RECALLED BY Elscint, Inc., Hackensack, New Jersey, by telephone on October 21, 1996, followed by letter on October 29, 1996. Firm-initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY 54 units were distributed. REASON The collimator fell off the head of a gamma camera onto the floor, possibly due to improper installation or design flaw. _______________ PRODUCT Series II Tibial Bearing Insert 15 mm Thickness, Size 5, implantable plastic accessory to a knee system. Recall #Z-487-8. CODE Catalog #3052-0515, Lot #17586801. MANUFACTURER Osteonics Corporation, Allendale, New Jersey. RECALLED BY Manufacturer, by telephone on February 14, 1997, followed by letter on February 25, 1997. Firm-initiated recall complete. DISTRIBUTION Minnesota, Iowa, Florida, Massachusetts, Japan. QUANTITY 8 units were distributed. REASON The product was designed to be 15mm in thickness, however, it was incorrectly finished with a 12mm thickness and then labeled as 15mm. The results of this manufacturing error is a dislocation of the tibial insert with the potential for restriction in flexing motion of the knee. _______________ PRODUCT Acclaim Infusion Pump, used to deliver parenteral infusion including whole blood, red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.. Recall #Z-498-8. CODE List No. 12032-04, all serial numbers. MANUFACTURER Abbott Laboratories, Critical Care Products, Morgan Hill, California. RECALLED BY Manufacturer, by letter dated March 30, 1998. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Florida, Maine, Mississippi, New Hampshire, North Carolina, Oklahoma, Rhode Island. QUANTITY 2,343 units were distributed. REASON Incorrect tubing setups which could lead to underinfusions. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Trypic Soy Agar Media Plates, recommended for use in qualitative procedures for the isolation and cultivation of a wide variety of organisms. Recall #Z-488-8. CODE Product #01-924, Lot 5550 EXP 11/13/96. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone on or about October 4, 1996. Firm-initiated recall complete. DISTRIBUTION Iowa and Colorado. QUANTITY 800 units were distributed. REASON The device does not support the growth of challenge organisms. _______________ PRODUCT N/F System (42P tube, GNF tube, Uni-N/F-Tek plate), a Nonfermenter System intended for the simple and rapid presumptive identification of the most frequently encountered clinical isolates of gram-negative aerobic bacteria which do not belong to the family Enterobacteriaceae (ie, the "other gram-negatives."). Recall #Z-492-8. CODE Product No. 73-10055, Lot No. 5513. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone on November 22, 1996. Firm-initiated recall complete. DISTRIBUTION Washington State, New Jersey, New York, California, Louisiana. QUANTITY 17 boxes 920 units per box) were distributed. REASON The correct color could not be obtained for a positive reaction. _______________ PRODUCT Vogel-Johnson Agar, a plated medium recommended for use in qualitative procedures for the early detection of coagulase-positive and mannitol-fermenting strains of Staphylococcus aureus from contaminated foods and clinical specimens. Recall #Z-493-8. CODE Product #01-970, Lot #5571 EXP 05/19/97, Segment #4. MANUFACTURER Remel Limited Partnership, Lenexa, Kansas. RECALLED BY Manufacturer, by telephone on March 17, 1997. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 90 units were distributed. REASON The media did not support growth and this lot did not meet its release criteria. _______________ PRODUCT Roche Online Amphetamine Kits, an in-vitro diagnostic test for the qualitative and semi-quantitative detection of amphetamine and methamphetamine and their metabolites in human urine: a) Order #43430; b) Order #43564. Recall #Z-494/495-8. CODE Lot numbers: a) 30247 EXP 12/97 and 24017 EXP 12/97; b) 56467 EXP 12/97 and 46017 EXP 12/97. MANUFACTURER Roche diagnostic Systems, Belleville, New Jersey. RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey (responsible firm), by letter on July 10, 1997, followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY a) 1,097 kits of lot 30247 and 303 kits of lot 24017; b) 643 kits of lot 56467 and 54 kits of lot 46017 were distributed. Firm estimates none remains on the market. REASON The reagents did not meet performance criteria throughout their assigned expiration date. _______________ PRODUCT Roche Creatinine Reagent, in-vitro diagnostic reagent system intended for use in the quantitative determination of creatinine serum, plasma and urine. Recall #Z-496-8. CODE Order No. 47003, Lot No. 00356 EXP 9/10/98. MANUFACTURER Roche Diagnostic Systems, Belleville, New Jersey. RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey, by letter on May 13, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY 1,733 kits were distributed; firm estimates none remains on the market. REASON The device has shown reduced reagent stability. END OF ENFORCEMENT REPORT FOR APRIL 15, 1998. BLANK PAGS MAY FOLLOW.End of Enforcement Report for