Recall record at a glance
| Official record | Z-1907-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Beckman Coulter Mishima K.K. |
| Report date | Jun 11, 2025 |
| Recall initiation date | Apr 30, 2025 |
| Quantity | 10,176 |
| Location | Sunto-Gun, N/A, Japan |
Official product description
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Why the product was recalled
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 information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.