Drug recall
Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device…
FDA recall event 66521 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 66521 |
|---|---|
| Recall numbers | Z-0519-2014 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i… |
| Initiation date | Oct 2, 2013 |
| Report date | Dec 25, 2013 |
| Termination date | Oct 23, 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: