FDA-Device2013-04-03Class II
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
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
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Affected count
386 kits (370 US, 16 OUS)
Manufactured in
20925 Crossroads Cir Ste 200, Waukesha, WI, United States
Products
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2013Don't want to check this manually?
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