Drug recall
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
FDA recall event 70678 · Class II · BD Biosciences, Systems & Reagents
Key facts
| Event ID | 70678 |
|---|---|
| Recall numbers | Z-1370-2015 |
| Recalling firm | BD Biosciences, Systems & Reagents |
| Product type | Devices |
| Products | BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation. |
| Initiation date | Mar 6, 2015 |
| Report date | Apr 8, 2015 |
| Termination date | Apr 4, 2016 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 2916837 |
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: