Beckman Coulter IRISpec CA/CB/CC control — Class III medical device recall Z-0984-2022
Ongoing recall by Beckman Coulter, Inc., reported 2022-04-27, distributed nationwide. IRISpec CA failures for glucose.
| Recall number | Z-0984-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2022-02-16 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CW, GT, MX, PH, SG, TW |
| Quantity | 12,306 kits |
| UPC / GTIN / UDI-DI | 10837461002611 |
| Lot numbers | 583-21 |
| Model numbers | 800-7211 |
Product
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
Reason for recall
IRISpec CA failures for glucose.
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-0984-2022. 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.