Recall archive / FDA device enforcement
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only. — FDA record Z-0777-2023
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 Nov 18, 2022. 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 control, REF 900-7211, For in vitro diagnostic use only.
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 3657 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0777-2023
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 565-21: 11-30-2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 11, 2023
- Recall initiation date
- Nov 18, 2022
- Center classification date
- Jan 3, 2023
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.