DATE RECALL INITIATED:
July 27, 2010
PRODUCT / LOT NUMBER/ EXPIRATION DATE:
Product: Verax Biomedical Platelet PGD Test Devices, P100T
Lot Numbers L06184; containing Test Device Lot 09345-001
Expiration Date: January 17, 2011
Lake Zurich, Illinois
Fenwal was informed by Verax BioMedical that a manufacturing problem was identified affecting Platelet PGD Test Devices (see above for lot numbers). This problem manifests itself as Non-Reactive Platelet PGD test results on the Gram-Negative side of the Test Device, even when testing known Gram-Negative samples. Verax determined that a small number of Platelet PGD Test Devices, have a defect that prevents the detection of Gram-Negative bacteria as both sides of the testing device may be manufactured with Gram-Positive conjugate bands. Verax has concluded that the overall risk of experiencing a falsely negative result when testing a platelet is extremely low. However, because there is a potential for a false negative to occur with the use of the affected lot, Fenwal is recommending customers immediately discontinue using this lot. Fenwal will be contacting customers to arrange for the return and replacement of 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.