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Genetic Testing Institute,inc recalls Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-link
Recalled April 3, 2013 · FDA recall Z-1022-2013 · Genetic Testing Institute,inc
Hazard
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 · FDA Class II
Units
386 kits (370 US, 16 OUS)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Description
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
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).
Manufacturer(s)
Genetic Testing Institute,inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →