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

Recall Z-1908-2025 — Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

U.S. FDA — Device Enforcement · Japan · 2025-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1908-2025
Date of alert
2025-04-30
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Mishima K.K.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14987666540732
Reported risk: Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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