Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount ...
FDA Recall #Z-1908-2025 — Class II — April 30, 2025
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.
Recalling Firm
Beckman Coulter Mishima K.K. — Sunto-Gun, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6,166
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, 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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.