Reported Sep 3, 2014 · Terminated
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test…
Nanosphere, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nanosphere, Inc. · 4088 Commercial Ave · Northbrook, IL · 60062-1829
Is this the product you have?
- Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
- Lot codes and dates
- (Catalog No. 20-005-019)
- Kit Numbers (US Distribution)
051013019-96288-16547-16420-15478-15802-16190-17360-35452-26499-16414-17183-17511-15225-15225-26495-15760-15779-17259-16783-17435-1
- Kit Numbers (Foreign Distribution)
7300-45500-15908-35970-36402-16402-26105-16123-16793-16827-16224-1
- Amount recalled
- 78 kits
Where it was sold
Why it was recalled
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 through internal testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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