Drug recall
Access Thyroglobulin Calibrators
FDA recall event 92670 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 92670 |
|---|---|
| Recall numbers | Z-0100-2024 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | Access Thyroglobulin Calibrators |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of… |
| Initiation date | Jul 6, 2023 |
| Report date | Oct 18, 2023 |
| 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: