Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot
Summary
The FDA issued a Class II for Sample probe sucks a sample dispensed into a tube or cup and discharges the ap by Beckman Coulter Mishima K.K.. Reason: Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not.
Details
Source
Device Recall
External ID
Z-1908-2025
Action Date
2025-06-11
Status
Completed
Category
device
Product Description
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Lot/Code Info: 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
Quantity Affected: 6,166
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, 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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-30
Company
Sunto-Gun, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Mishima K.K. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Mishima K.K.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Mishima K.K. have FDA actions?
Beckman Coulter Mishima K.K. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1908-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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