Drug recall
Access System-Free T4 Assay, B01902E, Catalog No. 33880
FDA recall event 77245 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 77245 |
|---|---|
| Recall numbers | Z-2635-2017, Z-2636-2017, Z-2637-2017, Z-2638-2017 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Access System-Free T4 Assay, B01902E, Catalog No. 33880, Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687, Access Thyroglobulin, A34085G, Catalog No. 33860, Access Total T3, A34435H, Catalog No. 33830 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Access immunoassays are susceptible to biotin interference. |
| Initiation date | May 9, 2017 |
| Report date | Jul 5, 2017 |
| Termination date | Mar 30, 2018 |
| 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: