Drug recall
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect…
FDA recall event 64054 · Class II · bioMerieux, Inc.
Key facts
| Event ID | 64054 |
|---|---|
| Recall numbers | Z-0738-2013 |
| Recalling firm | bioMerieux, Inc. |
| Product type | Devices |
| Products | BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. |
| Initiation date | Dec 25, 2012 |
| Report date | Feb 6, 2013 |
| Termination date | Jun 3, 2014 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3002769706 |
At a glance
- 1–9 Products in this recall
- 10–99 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: