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George King Pooled Normal Plasma
GEORGE KING BIO-MEDICAL, INC · Model 0010-1.5 · UDI-DI 00815696020122
GGN
Prescription
10
510(k) clearances
148
Adverse events
16
Recalls
43
Facilities
Description
George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-01 | Aniara Diagnostica LLC | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin |
| 2026-04-30 | Accriva Diagnostics, Inc. | Assayed Whole blood control contains labeling with incorrect performance range. |
| 2022-06-28 | Aniara Diagnostica LLC | Incorrect product labeling was included in the package. |
| 2019-11-18 | Diagnostica Stago, Inc. | A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for fact |
| 2019-03-19 | Aniara Diagnostica LLC | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. |
| 2019-03-19 | Aniara Diagnostica LLC | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. |
| 2019-03-19 | Aniara Diagnostica LLC | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. |
| 2016-02-18 | TEM Systems Inc | Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 201 |
| 2013-11-15 | Instrumentation Laboratory Co. | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval |
| 2013-11-15 | Instrumentation Laboratory Co. | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval |
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