Drug recall
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
FDA recall event 91854 · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Event ID | 91854 |
|---|---|
| Recall numbers | Z-1377-2023, Z-1378-2023 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Product type | Devices |
| Products | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD, BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against…, Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against… |
| Initiation date | Feb 21, 2023 |
| Report date | Apr 19, 2023 |
| City | Redmond |
| State | WA |
| Country | United States |
| FEI number | 3022521 |
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: