# FDA recall Z-1908-2025

> **Beckman Coulter Mishima K.K.** · Class II · device recall initiated 2025-04-30.

## Product

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.

## Distribution

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, IL, NE, OK, NV, SC, TN, MD, OR, AR, MS, AK, WI, DE, MT, HI, KS, ME, NH, WV, NM, CT, IA, MI, MN, ID, RI, SD, WY, ND, DC, VT, GUAM, PR and  OUS (foreign) to countries of: Viet Nam, Japan, India, Australia, El Salvador, China, United Arab Emirates, Thailand, Russian Federation, Italy, Germany, Korea (Republic of, Malaysia), Taiwan, Province of China, Turkey, Kazakhstan, Israel, Ecuador, Hungary, Egypt, Serbia, Bangladesh, Bosnia and Herzegovina, Costa Rica, Belarus, United Kingdom, Ireland, Botswana, Kenya, Mauritius, Ghana, Zambia, South Africa, Libya, Croatia, France, Switzerland, Czechia, Philippines, Namibia, Canada, Qatar, Azerbaijan, Lesotho, Bulgaria, Zimbabwe, Poland, Norway, Spain, Brazil, Tanzania (United Republic of), Lithuania, Yemen, Uzbekistan, Algeria, Somalia, Sri Lanka, Nepal, Pakistan, Ukraine, Peru, Morocco, Singapore, Slovakia, Me

## Key facts

- **Recall number:** Z-1908-2025
- **Recalling firm:** Beckman Coulter Mishima K.K.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-30
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunto-Gun, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1908-2025

## Citation

> AI Analytics. FDA recall Z-1908-2025. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-1908-2025. Source: US FDA. Licensed CC0.

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