FDA

Enforcement Report

CODE
All lots.

MANUFACTURER
Butterfield Foods, Pennville, Indiana.

RECALLED BY
Manufacturer, by press release on August 28, 1998, and by telephone and fax on August 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
States east of the Mississippi River.

QUANTITY
a) 2,400 tubs; b) 550 tubs were distributed.

REASON
Products are contaminated with Listeria monocytogenes.

CODE
Aspers Plant Code: A80302, A80304-A80306, A80313, A80315, A80317,A80318, A80320-A80325 Williamson Plant Code: WP80331, WP80401, WP80403, WP80404, WP80409, WP80411, WP80413, WP80414, WP80506, WP80507-WP80511.

MANUFACTURER
Manufacturing Plants: Mott's Inc. Williamson, New York and Mott's Inc., Aspers Pennsylvania.

RECALLED BY
Mott's North America, Stamford, Connecticut, by E-mail on August 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
376,406 cases were distributed.

REASON
Products contain Candida parapsilosis.

PRODUCT
Frozen Rock Lobster Tails in 10 pound cardboard boxes. Recall #F-008-9.

CODE
None.

MANUFACTURER
Interamerican Trading and Products Corporation, Medley, Florida.

RECALLED BY
Manufacturer, by letter on June 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida, Michigan, Kansas, South Carolina, Massachusetts, Georgia, Ohio, Tennessee, Illinois, California, Arizona, Wisconsin, Nevada, New York, Maryland, Washington state.

QUANTITY
Approximately 44,000 pounds were distributed.

REASON
Product contains undeclared sulfites.

PRODUCT
Mango Anchar in 12 ounce glass jars. Recall #F-010-9.

CODE
None.

MANUFACTURER
Maharaj Argo Products Inc., Trinidad.

RECALLED BY
Kwack Trading Company, Inc., Bronx, New York (importer), by placing a placard at the check out counter on May 2, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Undetermined.

QUANTITY
Undetermined.

REASON
Product contains an unapproved food additive namely mustard seed oil.

PRODUCT
Chief brand Kuchela West Indian Pickles, in 12 ounce glass jars. Recall #F-011-9.

CODE
None.

MANUFACTURER
Chief Brand Products, Trinidad.

RECALLED BY
Kwack Trading Company, Inc., Bronx, New York (importer), by placing a placard on the check-out counter on May 27, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Undetermined.

QUANTITY
Undetermined.

REASON
Product contained an unapproved food additive namely mustard seed oil.

CODE

Bulk Lot #    EXP Date    Lot Numbers

003740        1/99        004519, 004520, 004521, 004522
003754        2/99        005282, 005283, 005284, 005285
004744        3/99        005374, 005375, 005810, 005820
005571        4/99        006967, 006968, 006969, 006970
006018        5/99        007024, 007025, 007026, 007495
                          007852, 007866, 007101, 011097
007032        9/99        008521, 008656, 008657, 008963
                          009206
007042        8/99        009859, 009860, 009861
009891       10/99        011098, 011100, 011101.

RECALLED BY
Manufacturer, by letter on October 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
77,000 bottles of 100s and 206 bottles of 500s were distributed.

REASON
Subpotent.

CODE
Lot #4JA308 EXP 9/97.

MANUFACTURER
Perrigo Company, Allegan, Michigan.

RECALLED BY
Manufacturer, by letter dated May 15, 1995. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
10,044 bottles were distributed in October 1994.

REASON
Tablet discoloration and mold.

CODE
Lot G83-53B-2A3.

MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.

RECALLED BY
Manufacturer, by telephone and letter on August 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alaska, California, Ohio, Texas.

QUANTITY
20 vials were distributed.

REASON
Allergenic extract labeled as Mountain Cedar contains Red Cedar.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Single Donor Plasma; d) Platelets; e) Platelets Pooled, Platelets Expired; f) Platelets, Pheresis; g) Cryoprecipitated AHF; h) Cryoprecipitated AHF, Pooled; I) Source Leukocytes; j) Recovered Plasma. Recall #B-044/053-9.

CODE

  Unit numbers: 
Red Blood Cells  Units:   9766814, 9780722, 9790017, 9802473,
9803338, 9843139, 9847315, 9790170, 9796748, 9802442, 9793096,
9842332, 9800686, 9801072, 9852942, 9801657, 9842292, 9800610,
9769934, 9842601, 9846495;
Fresh Frozen Plasma Units:  9766814, 9780722, 9790017, 9798765,
9802473, 9803338, 9843139, 9790170, 9796748, 9793096, 9800686,
9852942, 9778045, 9799817, 9801657, 9800610, 9801093, 9842601;
Single Donor Plasma Units 9842332, 9842292 9842241;
Platelets Units  9766814, 8789460, 9802473, 9802442, 9842332,
9800686, 9799817, 9801657, 9842601;
Platelets Pooled Units 57950, 58657, 57592, 57352;
Platelets Expired Units 9801093, 9846495;
Platelets, Pheresis Unit 9771578;
Cryoprecipitated AHF Unit 9790483;
Cryoprecipitated AHF, Pooled Unit 59926
Leukocytes Units 9780722, 9790017, 9802473, 9800686;
Recovered Plasma Units 9789460, 9790483, 9803338, 9788435,
9771578, 9769934.

MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter on July 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Florida, Ohio, Kentucky.

QUANTITY
70 units of the various components were distributed.

REASON
Blood products were collected from donors whose donor history screening was incomplete.

PRODUCT
Allergenic Extract, Mosquito, Coffea Arabica, 5 ml Scratch-Prick Testing Vial. Recall #B-054-9.

CODE
Lot F703128A.

MANUFACTURER
Allergy Laboratories of Ohio, Inc., Columbus, Ohio.

RECALLED BY
Manufacturer, by letter dated September 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey and Ohio.

QUANTITY
2 vials were distributed.

REASON
Allergenic extract labeled as Mosquito, Coffea Arabica should have been labeled Mosquito, Culex sp.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-055/056-9.

CODE
Unit #29FC46209.

MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.

RECALLED BY
Manufacturer, by letter dated August 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit of ea

ch component was distributed. REASON
Blood products were collected from a donor with a history of hepatitis.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Source Leukocytes; d) Recovered Plasma. Recall #B-060/063-9.

CODE
Unit #01KF30834.

MANUFACTURER
American Red Cross Blood Services, Rochester, New York.

RECALLED BY
Manufacturer, by telephone on May 20, 1998, and by letter dated May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York and New Jersey.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose spouse had been diagnosed with hepatitis C.

PRODUCT
Source Leukocytes for Manufacturing. Recall #B-064-8.

CODE
Unit #01KH22591.

MANUFACTURER
American Red Cross Blood Services, Rochester, New York.

RECALLED BY
Manufacturer, by telephone on December 3, 1997, and by letter dated December 23, 1997. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a unsuitable donor.

PRODUCT
Red Blood Cells. Recall #B-065-9.

CODE
Unit #10584-2488.

MANUFACTURER
United Blood Services, Phoenix, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on June 23, 1998, and by letter dated July 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for HBsAg, but was collected from a donor who previously tested reactive for HBsAg.

PRODUCT
Red Blood Cells. Recall #B-068-9.

CODE
Unit #20267-8917.

MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 29, 1997, and by letter dated June 23, 1997. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

PRODUCT
Red Blood Cells. Recall #B-072-9.

CODE
Unit #18215-1322.

MANUFACTURER
United Blood Services, Cheyenne, Wyoming.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 31, 1997. Firm-initiated recall complete.

DISTRIBUTION
Wyoming.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that compromises the sterility of the product.

PRODUCT
Platelets. Recall #B-073-9.

CODE
Unit #39G00043.

MANUFACTURER
American Red Cross, Huntington, West Virginia.

RECALLED BY
Manufacturer, by letter dated July 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
West Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared using an unvalidated centrifuge.

PRODUCT
Red Blood Cells. Recall #B-078-9.

CODE

04R33500         04R33501         04R33502
04R33503         04R33504         04R33505
04R33506         04R33507         04R33508
04R33509         04R33510         04R33511
04R33513         04R33514         04R33515
04R33516         04R33517         04R33518
04R33519         04R33520         04R33521
04R33522         04R33523         04R33528
04R33529         04R33530         04R33531
04R33532         04R33533         04R33534
04R33535         04R33536         04R33537.

RECALLED BY
American Red Cross, Dedham, Massachusetts, by telephone on January 14, 1998, and by letter dated January 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
33 units were distributed.

REASON
Blood products were incorrectly tested for syphilis.

CODE
Unit #20268-2901.

MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated August 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who exceeded the donation acceptance criteria for body temperature.

PRODUCT
Platelets. Recall #B-069-9.

CODE
Unit #10586-0150.

MANUFACTURER
United Blood Services, Scottsdale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nevada.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time.

PRODUCT
Platelets. Recall #B-070-9.

CODE
Unit #20265-4557.

MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.

RECALLED BY
Manufacturer, by telephone on November 22, 1996. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time.

PRODUCT
Platelets. Recall #B-071-9.

CODE
Unit #20267-6650.

MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 2, 1997. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time.

PRODUCT
Platelets, Pheresis. Recall #B-074-9.

CODE
Unit numbers: 12431-7251, 12431-3380-01, 12431-3380-02.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado, Illinois, New Mexico.

QUANTITY
3 units were distributed.

REASON
Unlicensed blood products was distributed in intra and interstate commerce without obliteration of the firm's license.

PRODUCT
Red Blood Cells. Recall #B-075-9.

CODE
Units 12425-8386 and 12424-8417.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 13, 1997, and by letter dated September 17, 1997. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
2 units were distributed.

REASON
Blood products were stored at unacceptable temperatures.

PRODUCT
Red Blood Cells. Recall #B-076-9.

CODE
Unit numbers: 12427-7422, 12427-7430.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 24, 1997, and by letter dated December 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
2 units were distributed.

REASON
Blood products were stored at unacceptable temperatures.

CODE
All PC-4 pumps distributed to date.

MANUFACTURER
Alaris Medical Systems, Inc., San Diego, California.

RECALLED BY
Alaris Medical Systems, San Diego, California, by letter on September 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
7,380 units were distributed.

REASON
The devices have a software problem that causes the entire device to shut down when the system controller detects either an actual motor stall event, or a timing event that may be a motor stall.

PRODUCT
CPI Model No. 2881 Software Application, Version 1.3 for CPI Model Nos. 2901 and 2950 Programmer/Recorder/Monitors (PRM's) used to program Delta and Vista Multiprogrammable Pulse Generators. Recall #Z-062-9.

CODE
All Model 2881, Version 1.3 software.

MANUFACTURER
Guidant Corporation, St. Paul, Minnesota.

RECALLED BY
Manufacturer, by telephone, followed by letter dated September 18, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
500-600 programmers have the model 2881 software.

REASON
There is the potential for an inaccurate magnet rate value to be displayed when using the version 1.3 Software Application which can lead to an incorrect estimation of the device's actual battery status.

PRODUCT
Manan SUPER-CORE BIOPSY NEEDLE 18 ga X 15 cm, 20 ga X 15 cm, 18 ga X 9 cm, 16 ga X 20 cm, 16 ga X 15 cm, 14 ga X 9 cm, 20 ga X 20 cm and 18 ga X 20 cm, used to obtain soft tissue biopsies, such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen and lungs. Recall #Z-063-9.

CODE
All catalog numbers "VLT 14/9X" through "VLT 20/20X" and Lot Numbers 81391208 through 82182261 are involved in this field correction.

MANUFACTURER
Medical Device Technologies (MD Tech), Gainsville, Florida.

RECALLED BY
Manufacturer, by letter on September 11, 1998 and October 14, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
798 devices were distributed.

REASON
The clear plastic film of some of the device's pouch packaging may exhibit cuts thereby compromising the sterile barrier.

PRODUCT
NIR ON Ranger with SOX Premounted System, a sheath covered (SOX) coronary stent, premounted on a balloon catheter used as part of a delivery system:

a) Product No. H7491826916251, 16mm NIR on Ranger with Sox 2.5;
b) Product No. H7491826916301, 16mm NIR on Ranger with Sox 3.0;
c) Product No. H7491826916351, 16mm NIR on Ranger with Sox 3.5;
d) Product No. H7491826916401, 16mm NIR on Ranger with Sox 4.0;
e) Product No. H7491826925251, 25mm NIR on Ranger with Sox 2.5;
d) Product No. H7491826925301, 25mm NIR on Ranger with Sox 3.0;
f) Product No. H7491826925351, 25mm NIR on Ranger with Sox 3.5;
g) Product No. H7491826925401, 25mm NIR on Ranger with Sox 4.0;
h) Product No. H7491826932251, 32mm NIR on Ranger with Sox 2.5;
I) Product No. H7491826932301, 32mm NIR on Ranger with Sox 3.0;
j) Product No. H7491826932351, 32mm NIR on Ranger with Sox 3.5;
k) Product No. H7491826932251, 32mm NIR on Ranger with Sox 4.0.
Recall #Z-100/111-9.

MANUFACTURER
Boston Scientific/Scimed, Maple Grove, Minnesota.

RECALLED BY
Manufacturer, by press release on October 5, 1998, and by letter on October 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
The estimated amount shipped is between 33,000 and 36,000.

REASON
There are pinhole leaks in the balloon which results in the balloon not deploying and failing at 3-4 atm which is below the rated burst pressure.

CODE
Catalog (or Reorder Number) #369711 Lot Numbers: 6G856, Expiration Date: January '98 6H878, Expiration Date: February '98.

MANUFACTURER
Becton Dickinson Vacutainer Systems, Broken Bow, Nebraska.

RECALLED BY
Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey, by telephone/fax on October 6, 1997, and by letters mailed on November 13, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Japan, Singapore, Canada.

QUANTITY
98,000 units of lot 6G856 and601,000 units of lot 6H878 were distributed.

REASON
The device has a contaminant which inactivates the citrate causing an increased rate of clotting of blood specimens.

PRODUCT
Abbott TestPack RSV, list 2027-16 (20 test kit) and 2027-25 (20 test kit with positive control) ,an Enzyme Immunoassay for the Rapid Detection of Respiratory Syncytial Virus from nasopharyngeal aspirates, washes and swabs of young children with lower respiratory tract illnesses. Recall #Z-058/059-9.

CODE
Lot 43243M102, EXP 12/12/98.

MANUFACTURER
Abbott Laboratories, North Chicago, Illinois.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by letter dated August 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
111 kits were distributed; firm estimated that 50% remained on market at time of recall initiation.

REASON
Kits were packaged with incorrect specimen treatment cups.

PRODUCT
Abbott Vision Urea Nitrogen Test Pack list 1416-10, 10 tests per pack ,an in vitro diagnostic used with the Abbott Vision System for the quantitative determination of urea in anticoagulated whole blood, plasma or serum, used in the diagnosis and treatment of certain renal and metabolic diseases. Recall #Z-060-9.

CODE
Lots 36758M300, 37121M200 and 37120M200 EXP 9/1/98.

MANUFACTURER
Abbott Laboratories, North Chicago, Illinois.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by letter dated April 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
3,950 packs were distributed; firm estimates none remains on the market.

REASON
The urea nitrogen calibrations failed for the Y-Intercept out of range.

PRODUCT
Bartels Cytomegalovirus (CMV) Immediate Early Antigen (IEA), Indirect Fluorescent Antibody Kit. Recall #Z-061-9.

CODE
Kit Lot #8H645.

MANUFACTURER
Intracel Corporation, Issaquah, Washington.

RECALLED BY
Manufacturer, by letter September 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon, Missouri, Texas.

QUANTITY
6 kits were distributed.

REASON
The antibody reagent is mislabeled as the conjugate, and may lead to potential delay in diagnosis.

PRODUCT
Para-Pak Trichrome Stain, packed in plastic bottles, 500 ml per bottle, a microbiological product used for staining intestinal parasites in stool specimens: Catalog/Product Numbers are: 400101 (individual bottles) and 400112 (case of 12 bottles). Recall #Z-093/094-9.

CODE
Lot # 39.549, Expiration Date: 9/99.

MANUFACTURER
Meridian Diagnostics, inc., Cincinnati, Ohio.

RECALLED BY
Manufacturer, by telephone on August 27, 1998, followed by letter. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
512 bottles were distributed.

REASON
The stain was incorrectly formulated, resulting in poor background contrast which makes it difficult for the user to differentiate the parasites and may lead to inaccurate test results.

PRODUCT
Abbott AxSYM CMV IgG Reagent Pack, list 4B47-22, a microparticle enzyme immunoassay for the qualitative detection of immunological experience, and can be used semi-quantitatively with paired sera or plasma as an indication of past or current infection with Cytomegalovirus on the AxSYM System. Recall #Z-096-9.

CODE
kit lot 38519M201 EXP 3/11/99

MANUFACTURER
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois.

RECALLED BY
Manufacturer, by telephone on April 1-3, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Florida, Louisiana, Massachusetts, Minnesota, New Jersey, New York, Oklahoma, South Dakota.

QUANTITY
44 kits were distributed.

REASON
The Master Calibration Barcode packaged with the lot was erroneously coded to read Assay Number 743, which is the list number 4B47-20 Assay Number in the AxSYM software protocol. The lot should have been coded with Assay Number 742. The AxSYM System for U.S. customers will not recognize the Master Calibration Barcode and cannot run the reagents by a Master Calibration.

PRODUCT
Abbott Cell-Dyn 16 Tri-Level Whole Blood Reference Control, list 99109-01 (12 tubes) and 99105-01 (Half Pack - 6 tubes) an in-vitro diagnostic reagent tri-level whole blood quality control material used to monitor CBC and differential values obtained on the Cell-Dyn 300-800, 610, 900, 1300, 1400, 1500, 1600 and 1700 Systems. Recall #Z-097/098-9.

CODE
Kit Lot 16511 EXP 7/6/98.

MANUFACTURER
Abbott Laboratories, Diagnostics, Division, Santa Clara, California.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by letter dated March 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
11,310 kits were distributed.

REASON
The low-level control material recovered out of range low for the HCT, MCV and MCHC parameters.

PRODUCT
Abbott Cell-Dyn 26 Hematology Control, list 01H71-01 an in-vitro diagnostic reagent tri-level hematology reference control used to monitor results obtained on the Cell-Dyn 4000 Hematology System. Recall #Z-099-9.

CODE
Kit Lot CD038 EXP 4/30/98.

MANUFACTURER
R&D Systems, Inc., Minneapolis, Minnesota.

RECALLED BY
Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by letter dated March 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,061 kits were distributed.

REASON
The high-level control material recovered out of range low for NRBC and NRBS/100 WBC parameters.