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

Recall Z-1552-2026 — DxC 700 AU, REF: B86444, B86446

U.S. FDA — Device Enforcement · Japan · 2026-01-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1552-2026
Date of alert
2026-01-30
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)
14987666542545
Reported risk: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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