Z-0093-2025 Class III Ongoing
FDA device recall Z-0093-2025 was initiated by Beckman Coulter, Inc. on Jul 16, 2024 and is designated Class III. 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… The recall status is ongoing. Affected quantity: 5589 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 23, 2024
- Initiation Date
- Jul 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5589 units
Product Description
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.
Distribution Pattern
worldwide
Code Information
UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0093-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026