Drug recall
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic…
FDA recall event 68710 · Class III · Nanosphere, Inc.
Key facts
| Event ID | 68710 |
|---|---|
| Recall numbers | Z-2559-2014 |
| Recalling firm | Nanosphere, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 18, 2014 |
| Report date | Sep 3, 2014 |
| Termination date | Jul 2, 2015 |
| City | Northbrook |
| State | IL |
| Country | United States |
| FEI number | 3006028115 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: