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INFINITI® Warfarin Intellipac® Reagent Module

AUTOGENOMICS, INC · Model 03-2140-01 · UDI-DI 00850009370174

ODWODV Prescription
6
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Description

CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system

Recalls

DateFirmReason
2008-02-25Nanosphere, Inc.Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).

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Data 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.