Recall Z-1908-2025— Beckman Coulter Mishima K.K.

Name: FDA recall Z-1908-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-30

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Mishima K.K., initiated 2025-04-30. It names one FDA 510(k) clearance: K961274. Product: Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670. Reason: 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..

Recalling firm: Beckman Coulter Mishima K.K.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-30
Firm location: Sunto-Gun, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K961274 — OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.·cleared 1996-07-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.