Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Published October 23, 2024 · Recall initiated: July 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter, Inc.
- Distributor
- worldwide
- Lot
- UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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