Device product
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Z-1022-2013
Product summary
- Event
- Event 64501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 386 kits (370 US, 16 OUS)
- Official record key
device-enforcement:Z-1022-2013
Official wording
Reason: Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
Code information: Kit Lot Number 3000389
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Derived failure modes
-
Unknown
Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati