Recall Z-1907-2025— Beckman Coulter Mishima K.K.

Name: FDA recall Z-1907-2025
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: K981743. Product: Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670. Reason: A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results..

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

K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.·cleared 1998-06-09

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

A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.

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