FDA Device recall Z-1001-2015
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, H…
- FDA Device
- Class II
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class II recall of PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, H… by Genetic Testing Institute, citing 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 backgroun….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-15 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Genetic Testing Institute |
| Distribution | US |
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
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.
Identifiers
| code_info | Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2015%22
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