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Heparin/PF4 Antibody Serum Panel
AKERS BIOSCIENCES, INC. · Model 4036027 · UDI-DI 00708872000004
GGN
Prescription
1
510(k) clearances
148
Adverse events
16
Recalls
43
Facilities
Description
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
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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