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xTAG® CYP2C19 Kit v3

Luminex Molecular Diagnostics, Inc · Model I046B0427 · UDI-DI 00840487100172

NTI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.

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.