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DATE RECALL INITIATED :
February 13, 2001
PRODUCT / LOT NUMBER / EXPIRATION DATE :
Antibody to Human Immunodeficiency Virus Type 1 (HIVAG-1 Monoclonal HIV p24 Antigen Test Kit)
71843M101 4/19/2001
MANUFACTURER :
Abbott Laboratories
Abbott Park, Illinois
REASON :
Abbott Laboratories is recalling the above mentioned lot of HIVAG-1 Monoclonal HIV p24 Antigen Test Kit as a result of the product not meeting established product specifications. The test kit is used in the in-vitro detection of HIV-1 p24 antigen and is intended as a screening test for donated blood and plasma as well as an aid in the diagnosis and prevention of HIV-1 infection. Abbott Laboratories became aware that the Antibody to HIV-1 (Rabbit) component of the test kit does not meet the label claim for volume. The label of the component states that 27ml of fluid is in the vial, however, the vials contain approximately 21ml. The failure to deliver the Antibody to HIV-1 (Rabbit) component of the test kit to the reaction well could result in a false negative test. The recall notification instructs establishments that currently have in inventory the recalled product to discontinue use and discard the product.
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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