Drug recall
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent…
FDA recall event 74393 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 74393 |
|---|---|
| Recall numbers | Z-2108-2016 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Demonstrate an upward shift in patient results. |
| Initiation date | Jun 8, 2016 |
| Report date | Jul 6, 2016 |
| Termination date | Apr 18, 2017 |
| 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: