Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-77...
FDA Recall #Z-0093-2025 — Class III — July 16, 2024
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.
Recalling Firm
Beckman Coulter, Inc. — Miami, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
5589 units
Distribution
worldwide
Code Information
UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated