Drug recall
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of…
FDA recall event 68309 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 68309 |
|---|---|
| Recall numbers | Z-1737-2014 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws. |
| Initiation date | May 14, 2014 |
| Report date | Jun 18, 2014 |
| Termination date | Dec 25, 2014 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
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: