Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gen-Probe LIFECODES PF4 Enhanced assay Recalled by Genetic Testing Institute,inc Due to Lifecodes PF4 Enhanced assay, lot number 3000389, is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Genetic Testing Institute,inc directly.
Affected 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).
Quantity: 386 kits (370 US, 16 OUS)
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Genetic Testing Institute,inc
Genetic Testing Institute,inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report