Official recall record
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 17943367 (ref Z-1908-2025)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-04-30
- Country of alert
- Japan
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 14987666540732
- Brand on record
- Beckman Coulter Mishima K.K.
What the authority reported
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.
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.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-03 · US FDA — Medical Devices
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: - 2026-01-30 · US FDA — Medical Devices
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 - 2026-01-30 · US FDA — Medical Devices
DxC 700 AU, REF: B86444, B86446
All 7 official recall notices naming Beckman Coulter Mishima K.K. on this site →
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