Nanosphere Recalls Verigene CYP2C19 Nucleic Acid Test Kits
Nanosphere is recalling 78 Verigene CYP2C19 Nucleic Acid Test kits due to an unacceptable increase in initial no-call rates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which by definition is unlikely to cause adverse health consequences. The issue is a performance defect (no-call rate) rather than a direct safety hazard like contamination or injury.
Plain-English summary
Nanosphere, Inc. is recalling 78 kits of the Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each kit contains 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays with Tip Holder Assemblies. The product is a clinical laboratory test.
The recall was initiated after Nanosphere received reports of an unacceptable increase in the initial no-call rate when performing the test. The company confirmed these issues through internal testing. The affected kits were distributed worldwide, including in the United States (AL, CA, MD, ND, NJ, OK, and TX) and internationally to Bulgaria, China, and New Zealand.
Clinical laboratories and healthcare facilities should stop using the affected kits and contact Nanosphere for instructions on return or replacement. Specific kit numbers for US and foreign distribution are listed in the official recall notice.
The recalled product
- Product
- 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.
- Manufacturer
- Nanosphere, Inc.
- Hazard
- Affected units
- 78
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (Catalog No. 20-005-019) Kit Numbers (US Distribution): 051013019-9
- 6288-1
- 6547-1
- 6420-1
- 5478-1
- 5802-1
- 6190-1
- 7360-3
- 5452-2
- 6499-1
- 6414-1
- 7183-1
- 7511-1
- 5225-1
- 5225-2
- 6495-1
- 5760-1
- 5779-1
- 7259-1
- 6783-1
Distribution
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