Recall archive / FDA device enforcement
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnos... — FDA record Z-0093-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 16, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
- Reason
- 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.
- Classification
- Class III
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 5589 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0093-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 10837461002611, Lot Numbers: 432-24 and higher |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 23, 2024
- Recall initiation date
- Jul 16, 2024
- Center classification date
- Oct 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.