Verigene CYP2C19 Nucleic Acid Test — Class III medical device recall Z-2559-2014
Terminated recall by Nanosphere, Inc., reported 2014-09-03, distributed in AL, CA, MD, ND, NJ, OK, TX. Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing th
| Recall number | Z-2559-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nanosphere, Inc., Northbrook, IL, United States |
| Recall initiated | 2014-03-18 |
| Classified | 2014-08-28 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-07-02 |
| Distributed | AL, CA, MD, ND, NJ, OK, TX |
| Countries outside the US | BG, CN, NZ |
| Quantity | 78 kits |
| Model numbers | 20-005-019 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2559-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.