Gen-Probe LIFECODES PF4 Enhanced assay — Class II medical device recall Z-1022-2013
Terminated recall by Genetic Testing Institute,inc, reported 2013-04-03, distributed nationwide. Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate
| Recall number | Z-1022-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genetic Testing Institute,inc, Waukesha, WI, United States |
| Recall initiated | 2013-02-04 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2016-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, ES, SK |
| Reason classes | potency |
| Lot numbers | 3000389 |
| Model numbers | PF4, X-HAT45GTI |
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).
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1022-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.