Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate… Recall
Issued June 11, 2025 · Beckman Coulter Mishima K.K.
In June 2025, Beckman Coulter Mishima K.K. recalled the Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter Mishima K.K. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Beckman Coulter Mishima K.K.
- Category
- Health
- Recall date
- June 11, 2025
- Units affected
- Not reported
- Sold at
- Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX, NJ, FL, IN, MA, NY, NC, OH, LA, AZ, MO, WA, GA, UT, KY, AL, CO,
- Recall number
- FDA-Z-1907-2025
- Made in
- Japan
- Issuing agency
- FDA
In context
- Beckman Coulter Mishima K.K. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.