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George King Factor IX Deficient Plasma
GEORGE KING BIO-MEDICAL, INC · Model 0900-1.0 · UDI-DI 00815696020009
GJT
Prescription
10
510(k) clearances
14
Adverse events
3
Recalls
11
Facilities
Description
George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors
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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