Home / Recalls / Beckman Coulter Mishima K.K. / Z-1907-2025

Z-1907-2025 Class II

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

FDA device recall Z-1907-2025 was initiated by Beckman Coulter Mishima K.K. on April 30, 2025 and is designated Class II. 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 … Affected quantity: 10,176.

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: 10,176

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.

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: AU480: B11810/14987666540664, B12183/14987666540671, B80091/16954701010015, B96692/14987666542965, B96693/14987666542972, C02654/14987666543283, C02655/14987666543290, C02845/16954701010022, C41919/14987666544174, C41920/14987666544181, N3659700/14987666535257, N3659800/14987666535264, N3659900/14987666535271, N3660000/14987666535288, N3660100/14987666535547, N3660200/14987666535554, N3660300/14987666535554, N3660400/14987666535769, N3660500/14987666536032, N3660600/14987666536049, N3660800/14987666536063, N3912400/14987666537084, N3912500/14987666537091, N3150700, N3151000, N3151300, N3151400, N3151500, N3151600, N3151900/ Serial: From 10155 to 2025021482. Sample Probe: MU993400/04987666522939, Lots: From 178713114 to 179433670. B66751 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-1908-2025 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)