Drug recall
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to…
FDA recall event 63467 · Class II · Biomerieux Inc
Key facts
| Event ID | 63467 |
|---|---|
| Recall numbers | Z-0299-2013, Z-0300-2013, Z-0301-2013, Z-0302-2013, Z-0303-2013, Z-0304-2013, Z-0305-2013, Z-0306-2013, Z-0307-2013, Z-0308-2013, Z-0309-2013, Z-0310-2013 and 19 more |
| Recalling firm | Biomerieux Inc |
| Product type | Devices |
| Products | bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are…, bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that…, bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that…, bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that…, bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that… and 26 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
| Initiation date | Oct 16, 2012 |
| Report date | Nov 28, 2012 |
| Termination date | Oct 28, 2013 |
| City | Hazelwood |
| State | MO |
| Country | United States |
| FEI number | 1950204 |
At a glance
- 10–99 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: