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INFINITI® Factor II BioFilmChip® Microarray Magazine
AUTOGENOMICS, INC · Model 01-1020-01 · UDI-DI 00850009370044
5
510(k) clearances
5
Adverse events
2
Recalls
4
Facilities
Description
Genotyping system for the detection of Factor II (Prothrombin) G20210A mutations.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-10-26 | Roche Diagnostics Operations, Inc. | If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the |
| 2009-03-12 | Roche Molecular Systems, Inc. | Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and the |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.