Home › Device types › GJT
Plasma, Coagulation Factor Deficient
FDA product code GJT · Class 2 · Hematology
112
Registered devices
14
Adverse events
3
Recalls
79
510(k) clearances
Devices with this code
STA® - Deficient XII — DIAGNOSTICA STAGOThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsCoagulation Factor XI Deficient Plasma — Siemens Healthcare Diagnostics Products GmbHGeorge King Factor X Deficient Plasma — GEORGE KING BIO-MEDICAL, INCCRYOcheck Factor VIII Deficient Plasma with VWF — Precision Biologic IncCRYOcheck™ Factor X Deficient Plasma — Precision Biologic IncThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsGeorge King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INCSTA® - Deficient V — DIAGNOSTICA STAGOCoagulation Factor II Deficient Plasma — Siemens Healthcare Diagnostics Products GmbHCRYOcheck™ Factor VII Deficient Plasma — Precision Biologic IncHemosIL Factor XII Deficient Plasma (10 X 1 mL) — INSTRUMENTATION LABORATORY COMPANYGeorge King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INCGeorge King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INCSTA® - Liatest® VWF:Ag — DIAGNOSTICA STAGOCRYOcheck™ Factor XII Deficient Plasma — Precision Biologic IncThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsHemosIL Factor VIII Deficient Plasma (10 X 1 mL) — INSTRUMENTATION LABORATORY COMPANYSTA® - Deficient X — DIAGNOSTICA STAGOCoagulation Factor XII Deficient Plasma — Siemens Healthcare Diagnostics Products GmbHGeorge King Factor VIII Deficient Plasma — GEORGE KING BIO-MEDICAL, INCGeorge King Factor IX Deficient Plasma — GEORGE KING BIO-MEDICAL, INCCoagulation Factor V Deficient Plasma — Siemens Healthcare Diagnostics Products GmbHCoagulation Factor X Deficient Plasma — Siemens Healthcare Diagnostics Products GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-05-11 | Siemens Healthcare Diagnostics, Inc. | Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range. |
| 2013-01-28 | Diagnostica Stago, Inc. | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. |
| 2005-07-08 | Dade Behring , Inc. | sample may exhibit falsely high results |
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