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DATE RECALL INITIATED:
June 24, 2004
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate, Lot No. E09569, found in kit Lot No. E11360, Material No. 21118560018, expiration January, 2005
Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase)BGG Conjugate, Lot No. E09569, found in kit Lot No. E11231, Material No. 21117750123, expiration September, 2004
NOTE: This product was only distributed to foreign consignees.
MANUFACTURER:
Roche Molecular Systems, Inc
Belleville, New Jersey
REASON:
Roche has confirmed increased frequency of occurrence of "blue foci" with the Avidin-Horseradish Peroxidase (AV-HRP) Conjugate Lot E09659. This lot is included as a component in the kits listed above. "Blue foci" are blue particulates in the microwell plate that are visible in manual methods following the addition of conjugate and substrate to the wells during the detection process. Increased frequency of the occurrence of "blue foci" may lead to elevated and/or observed out of sequence optical density readings in the microwell plate assays that have used this particular lot of reagent. The investigation determined that AV-HRP Conjugate, Lot E09659, exhibited a higher frequency of "blue foci" when compared to previous lots of conjugate, and that the frequency of blue foci in this particular lot may be increasing with the age of the reagent. Consignees have been asked to contact the manufacturer to arrange for product return.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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