Recall Z-2559-2014 ยท NTI Drug Metabolizing Enzyme Genotyping Systems
Nanosphere, Inc.
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.
| Date | Aug 28, 2014 (initiated Mar 18, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Nanosphere sent an Field Notification Letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions for customers to: 1) discontinue use of the affected products, 2) discard the affected product, and 3) complete and return the attached for to obtain free-of-charge replacement kits. Customers with any questions about this recall should contact their Nanosphere technical support representative at 1 888 837-4436. . |
| Quantity | 78 kits |
| Distribution | Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) Nanosphere, Inc., Nov 6, 2012 |