Home › Device types › KFF
Assay, Heparin
FDA product code KFF · Class 2 · Hematology
30
Registered devices
33
Adverse events
12
Recalls
46
510(k) clearances
Devices with this code
STA® - Liquid Anti-Xa 4 — DIAGNOSTICA STAGOBIOPHEN HEPARIN 6 — HYPHEN BIOMEDHemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Dade® Ci-Trol® Heparin Control, Low — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Heparin — Siemens Healthcare Diagnostics Products GmbHStachrom® Heparin — DIAGNOSTICA STAGOBerichrom® Heparin — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Heparin — Siemens Healthcare Diagnostics Products GmbHSTA® - Hepanorm® HBPM/LMWH — DIAGNOSTICA STAGOHemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Dade® Ci-Trol® Heparin Control, High — Siemens Healthcare Diagnostics Products GmbHACTICHROME Heparin (Anti-FIIa) — Biomedica ADI Inc.STA® - Liquid Anti-Xa 8 — DIAGNOSTICA STAGOSTA® - Hepanorm® H — DIAGNOSTICA STAGOBIOPHEN HEPARIN 3 — HYPHEN BIOMEDDade Ci-Trol Heparin Control, High — Siemens Healthcare Diagnostics Products GmbHHemosIL Liquid Anti-Xa — INSTRUMENTATION LABORATORY COMPANYHemosIL Heparin — INSTRUMENTATION LABORATORY COMPANYHemosIL Liquid Heparin — INSTRUMENTATION LABORATORY COMPANYHemosIL LMW Heparin Controls — INSTRUMENTATION LABORATORY COMPANYHemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-21 | Diagnostica Stago, Inc. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2025-07-21 | Diagnostica Stago, Inc. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2025-02-03 | Instrumentation Laboratory | Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert ac |
| 2024-12-18 | Instrumentation Laboratory | Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance ran |
| 2023-02-03 | Instrumentation Laboratory | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| 2023-02-03 | Instrumentation Laboratory | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| 2023-02-03 | Instrumentation Laboratory | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| 2023-02-03 | Instrumentation Laboratory | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| 2021-08-25 | Instrumentation Laboratory | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days |
| 2014-07-18 | Diagnostica Stago, Inc. | Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. |
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