PF4 Concentrated Wash — Class II medical device recall Z-1001-2015
Terminated recall by Genetic Testing Institute,inc, reported 2015-01-28, distributed nationwide. Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly i
| Recall number | Z-1001-2015 |
|---|---|
| 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 | 2014-12-15 |
| Classified | 2015-01-20 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2015-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, GB, JP, TH, TW |
| Quantity | 6,206 kits |
| Reason classes | potency |
| Lot numbers | 3001620, 3001987, 3002083, 3002153 |
| Model numbers | 403624, HAT13G, HAT45G, X-HAT13, X-HAT45 |
Product
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.
Reason for recall
Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
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-1001-2015. 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.