Drug recall
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test…
FDA recall event 68831 · Class II · Nanosphere, Inc.
Key facts
| Event ID | 68831 |
|---|---|
| Recall numbers | Z-2236-2014 |
| Recalling firm | Nanosphere, Inc. |
| Product type | Devices |
| Products | Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have… |
| Initiation date | Jul 9, 2014 |
| Report date | Aug 20, 2014 |
| Termination date | Sep 1, 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: