Drug recall
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
FDA recall event 86386 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 86386 |
|---|---|
| Recall numbers | Z-3006-2020 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. |
| Initiation date | Aug 26, 2020 |
| Report date | Sep 30, 2020 |
| Termination date | May 24, 2024 |
| 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: