BECKMAN COULTER IRISpec CA/CB/CC control — Class II medical device recall Z-0777-2023
Ongoing recall by Beckman Coulter, Inc., reported 2023-01-11, distributed in PR. Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB g
| Recall number | Z-0777-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2022-11-18 |
| Classified | 2023-01-03 |
| Reported by FDA | 2023-01-11 |
| Distributed | PR |
| Countries outside the US | BR, CA, KR, MX, TW |
| Quantity | 3,657 units |
| UPC / GTIN / UDI-DI | 10837461002611 |
| Lot numbers | 565-21 |
| Model numbers | 900-7211 |
Product
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Reason for recall
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
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-0777-2023. 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.