Home › Device types › LCO
Platelet Factor 4 Radioimmunoassay
FDA product code LCO · Class 2 · Hematology
21
Registered devices
31
Adverse events
13
Recalls
13
510(k) clearances
Devices with this code
PF4 Enhanced® — IMMUCOR GTI DIAGNOSTICS, INC.Positive Serum Control — IMMUCOR GTI DIAGNOSTICS, INC.Asserachrom® PF4 — DIAGNOSTICA STAGOHemosIL HIT-Ab(PF4-H) — INSTRUMENTATION LABORATORY COMPANYAsserachrom® HPIA — DIAGNOSTICA STAGOPF4 IgG — IMMUCOR GTI DIAGNOSTICS, INC.ZYMUTEST HIA IgGAM — HYPHEN BIOMEDZYMUTEST HIA MonoStrip IgGAM — HYPHEN BIOMEDSpecimen Diluent — IMMUCOR GTI DIAGNOSTICS, INC.PF4 IgG — IMMUCOR GTI DIAGNOSTICS, INC.PF4 Enhanced® — IMMUCOR GTI DIAGNOSTICS, INC.PIFA PLUSS® PF4 Rapid Assay — AKERS BIOSCIENCES, INC.HemosIL CL HIT-IgG (PF4-H) — INSTRUMENTATION LABORATORY COMPANYAnti-Human IgG/A/M Conjugate — IMMUCOR GTI DIAGNOSTICS, INC.HemosIL AcuStar HIT-IgG (PF4-H) — INSTRUMENTATION LABORATORY COMPANYAnti-Human IgG Conjugate — IMMUCOR GTI DIAGNOSTICS, INC.Negative Serum Control — IMMUCOR GTI DIAGNOSTICS, INC.PF4 Concentrated Wash (10x) — IMMUCOR GTI DIAGNOSTICS, INC.ZYMUTEST HIA MonoStrip IgG — HYPHEN BIOMEDPIFA® Heparin/PF4 Rapid Assay — AKERS BIOSCIENCES, INC.ZYMUTEST HIA IgG — HYPHEN BIOMED
Recent 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| Aniara Diagnostica LLC | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the pos |
| 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 |
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