Drug recall
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
FDA recall event 94012 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 94012 |
|---|---|
| Recall numbers | Z-1303-2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | Access Total T4, REF 33800, IVD, thyroxine reagent assay. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. |
| Initiation date | Feb 8, 2024 |
| Report date | Mar 27, 2024 |
| City | Chaska |
| State | MN |
| Country | United States |
| FEI number | 2122870 |
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: