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PF4 Enhanced®
IMMUCOR GTI DIAGNOSTICS, INC. · Model X-HAT45 · UDI-DI 10888234500032
LCO
Prescription
10
510(k) clearances
31
Adverse events (1 deaths)
13
Recalls
7
Facilities
Description
PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-03 | Instrumentation Laboratory | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| 2026-09-03 | Instrumentation Laboratory | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| 2026-04-01 | Aniara Diagnostica LLC | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. |
| 2025-12-15 | Diagnostica Stago, Inc. | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. |
| 2019-07-19 | Aniara Diagnostica LLC | Residual crystallization of the microplate and recurrent negative controls out of range. |
| 2019-07-19 | Aniara Diagnostica LLC | Residual crystallization of the microplate and recurrent negative controls out of range. |
| 2018-02-05 | Hyphen BioMed | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| 2018-02-05 | Hyphen BioMed | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| 2018-02-05 | Hyphen BioMed | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| 2014-12-15 | Genetic Testing Institute,inc | 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 |
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