Class II Recall

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: 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.

Details

Source

Device Recall

External ID

Z-1907-2025

Action Date

2025-06-11

Status

Completed

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: 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

Quantity Affected: 10,176

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

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

Beckman Coulter Mishima K.K.

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-1907-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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