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INFINITI® CYP2C19 Amplification Mix

AUTOGENOMICS, INC · Model 03-3220-01 · UDI-DI 00850009370150

NTI NSU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

CYP2C19 drug metabolyzing enzyme genotyping system

Recalls

Date	Firm	Reason
2014-03-18	Nanosphere, Inc.	Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed
2011-05-24	Luminex Corporation	Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
2007-03-09	Roche Molecular Systems, Inc.	The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I re
2007-03-09	Roche Molecular Systems, Inc.	The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I re

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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.