Drug recall
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels…
FDA recall event 72408 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 72408 |
|---|---|
| Recall numbers | Z-0239-2016 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. |
| Initiation date | Oct 13, 2015 |
| Report date | Nov 18, 2015 |
| Termination date | Apr 13, 2016 |
| 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: