Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls — Class III medical device recall Z-0093-2025
Ongoing recall by Beckman Coulter, Inc., reported 2024-10-23. Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative gl
| Recall number | Z-0093-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2024-07-16 |
| Classified | 2024-10-16 |
| Reported by FDA | 2024-10-23 |
| Quantity | 5,589 units |
| UPC / GTIN / UDI-DI | 10837461002611 |
| Lot numbers | 432-24 |
| Model numbers | 800-7211, 800-7702 |
Product
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Reason for recall
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
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-0093-2025. 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.