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System, Fibrinogen Determination
FDA product code KQJ · Class 2 · Hematology
33
Registered devices
6
Adverse events
3
Recalls
28
510(k) clearances
Devices with this code
Dade Thrombin Reagent — Siemens Healthcare Diagnostics Products GmbHKaolin Suspension — Siemens Healthcare Diagnostics Products GmbHTriniCLOT™ Imidazole Buffer — TCOAG IRELAND LIMITEDTriniCLOT™ Thrombin Time 4ml — TCOAG IRELAND LIMITEDFibrinogen Assay Kit — HELENA LABORATORIES CORPORATIONCalcium Chloride — Bio/Data CorporationDade® Data-Fi® Abnormal Fibrinogen Control — Siemens Healthcare Diagnostics Products GmbHHemosIL Fibrinogen-C XL — INSTRUMENTATION LABORATORY COMPANYKaolin Suspension — Siemens Healthcare Diagnostics Products GmbHSTA® - Fibrinogen 5 — DIAGNOSTICA STAGODade Owren's Veronal Buffer — Siemens Healthcare Diagnostics Products GmbHMultifibren U — Siemens Healthcare Diagnostics Products GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsHelena Fibrinogen Calibrator — HELENA LABORATORIES CORPORATIONDade® CA System Buffer — Siemens Healthcare Diagnostics Products GmbHDade CA System Buffer — Siemens Healthcare Diagnostics Products GmbHMultifibren U — Siemens Healthcare Diagnostics Products GmbHTriniCLOT™ Fibrinogen Kit — TCOAG IRELAND LIMITEDHuman Fibrinogen BINDARID™ Radial Immunodiffusion Kit — THE BINDING SITE GROUP LIMITEDHemosIL Low Fibrinogen Control — INSTRUMENTATION LABORATORY COMPANYMultifibren® U — Siemens Healthcare Diagnostics Products GmbHDade Thrombin Reagent — Siemens Healthcare Diagnostics Products GmbHDade® Owren's Veronal Buffer — Siemens Healthcare Diagnostics Products GmbHDade® Thrombin Reagent — Siemens Healthcare Diagnostics Products GmbH
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. |
| 2017-05-19 | Fisher Diagnostics | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651 |
| 2017-05-19 | Fisher Diagnostics | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651 |
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