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

Recall Z-1606-2023 — Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

U.S. FDA — Device Enforcement · United States · 2023-04-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1606-2023
Date of alert
2023-04-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590020187
Reported risk: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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