ProductGuru Recalls

Official recall record

Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

US FDA — Medical Devices · 2024-07-16 · United StatesClass III
Issuing authority
US FDA — Medical Devices
Alert date
2024-07-16
Country of alert
United States
Alert level
Class III
Alert type
recall
Barcode (EAN/GTIN)
10837461002611
Brand on record
Beckman Coulter, Inc.
Product category
Medical Device

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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