BioPlex 2200 ANA Screen Control Set — Class II medical device recall Z-0082-2022
Terminated recall by Bio-Rad Laboratories, Inc., reported 2021-10-20, distributed nationwide. A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA
| Recall number | Z-0082-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Redmond, WA, United States |
| Recall initiated | 2019-11-01 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2023-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 206 |
| Lot numbers | 300884, 300907, 300928, 300933, 50661, 50726, 50835, 50858, 51765 |
| Model numbers | 663-1101, 663-1131, 665-1150 |
| Expiration dates | 2021-03-05 |
Product
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
Reason for recall
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0082-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.