Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0093-2025 — Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

U.S. FDA — Device Enforcement · United States · 2024-07-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0093-2025
Date of alert
2024-07-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Beckman Coulter, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10837461002611
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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