Home / Recalls / Beckman Coulter Mishima K.K. / Z-1908-2025

Z-1908-2025 Class II

Recalled by Beckman Coulter Mishima K.K. — Sunto-Gun, N/A

FDA device recall Z-1908-2025 was initiated by Beckman Coulter Mishima K.K. on April 30, 2025 and is designated Class II. 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 t… Affected quantity: 6,166.

Recall Details

Product Type: Devices
Report Date: June 11, 2025
Initiation Date: April 30, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,166

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.

Distribution Pattern

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, Mexico, Myanmar, Lebanon, Jordan, Malawi, Greece, Indonesia, Chile, Romania, Georgia, Ethiopia, Sweden, Albania, Eswatini, Nigeria, Cote d'Ivoire, Argentina, Dominican Republic, Iraq, Maldives, Saudi Arabia, Kuwait, Austria, Eritrea, Bolivia (Plurinational State of), Tunisia, Curacao, Mozambique, Hong Kong, Bahrain, Portugal, Panama, New Zealand, Colombia, Uganda, Oman, Belgium, Saint Pierre and Miquelon, Guyana, Macao, Cabo Verde, Sint Maarten (Dutch part), Liberia, Moldova, Republic of, North Macedonia, Congo (Democratic Republic of the), Uruguay, Cyprus, Netherlands, Suriname, Slovenia, Denmark, Finland, Venezuela, Sierra Leone

Code Information

Device: REF/UDI-DI/Serial-Lot: AU680: B12185/14987666540732, B12186/14987666540688, B12187/14987666540701, B12188/14987666540725, B96694/14987666542989, B96695/14987666542996, B96696/14987666543009, C02656/14987666543306, C02657/14987666543313, N3147700/15099590346249, N3662000/14987666535301, N3662100/14987666535318, N3662200/14987666535325, N3662700/14987666535615, N3663000/14987666535646, N3910200/14987666535790, N3910400/14987666535813, N3910500/14987666535820, N3910600/14987666535912, N3910800/14987666535936, N3910900/4987666535946, N3911200/14987666535974, N3911700/14987666536575, N3911900/14987666536599, N3147100, N3147200, N3147300, N3147400, N3147600, N3148100, N3149400, N3149800. Serial: From 10436 to 2022087656. Sample Probe: MU993400/04987666522939, Lots: From 178713114 to 179433670. B66752 Kits containing MU993400, Lots: From 178713114 to 179433670

Other recalls by Beckman Coulter Mishima K.K.

Z-1553-2026 Class II — CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 (January 30, 2026)
Z-1552-2026 Class II — DxC 700 AU, REF: B86444, B86446 (January 30, 2026)
Z-1907-2025 Class II — Sample probe sucks a sample dispensed into a tube or cup and discharges the ap (April 30, 2025)
Z-2691-2024 Class II — DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry (July 10, 2024)
Z-2455-2024 Class II — DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry (June 5, 2024)