Lower risk Medical device recall · FDA · Published April 30, 2025

Beckman Coulter Sample Probe Recall: Defective Probe Mixes Sample Water

Beckman Coulter recalls sample probes with defective tips that mix cleaning water and sample, causing inaccurate test results. Affected units sold between specific dates and serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1907-2025Medical device Beckman Coulter ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBeckman Coulter Mishima K.K.454-32, Higashino; Nagaizumi-Cho · Sunto-Gun, Japan

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling sample probes that may mix cleaning water with the sample during use. This causes the sample to be diluted, leading to inaccurate test results. Affected units have specific serial numbers and were sold between certain dates. Read more at govinfonow.com/recall/52364-beckman-coulter-sample-probe-recall-defective-probe-mixes-sample-water.

Source Summary by GovInfoNow · govinfonow.com/recall/52364-beckman-coulter-sample-probe-recall-defective-probe-mixes-sample-water · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1907-2025

Cite this page

“Beckman Coulter Sample Probe Recall: Defective Probe Mixes Sample Water.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52364-beckman-coulter-sample-probe-recall-defective-probe-mixes-sample-water. Based on FDA recall #Z-1907-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1907-2025%22&limit=1).

Beckman Coulter Mishima K.K. recalled sample probes worldwide on April 30, 2025, according to the FDA. A manufacturing defect can cause cleaning water and samples to mix, leading to lower-than-expected analyte concentrations. The agency announced the Class II recall under number Z-1907-2025.

How to tell if you have it

Brand: Beckman Coulter
Product: Sample probe (S probe)
Lot numbers: 178713114 - 179433670
Device/Serial/Lot codes: 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 numbers: From 10155 to 2025021482
Sample Probe codes: MU993400/04987666522939, Lots: From 178713114 to 179433670
B66751 Kits containing MU993400, Lots: From 178713114 to 179433670
Units affected: 10,176

The hazard

The FDA said a manufacturing defect in the sample probe causes the corners of the tip to be rounded and chamfered. This prevents the proper formation of an air layer that normally separates cleaning water from the sample. Consequently, the two mix and dilute the sample, resulting in analyte concentrations measured lower than expected.

Context

GovInfoNow's records show Beckman Coulter Mishima K.K. has had four other recalls on record since June 5, 2024. Other recent recalls of similar products include AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (Aug. 3, 2026), Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (Jan. 30, 2026), and Beckman Coulter DxC 500 AU Analyzer Recall: Software Error Causes Delayed Results (July 10, 2024). Additional recent recalls include Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (Dec. 23, 2025), Beckman Coulter Bicarbonate Reagent May Cause False High Results - Recall (Oct. 14, 2025), and Beckman Coulter Access 2 Reaction Vessels Recall: Small Deformity May Cause Instrument Errors (Nov. 7, 2025).

How to tell if you have this one

Check the serial number on the probe or the lot number on the packaging. Affected probes have serial numbers from 10155 to 2025021482 and were sold with specific lots between 178713114 and 179433670.

Brand
Beckman Coulter
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Completed
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

Recall number	Product, codes & lots	Quantity
Z-1907-2025	Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670; 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	10,176
Z-1908-2025	Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670; 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	6,166

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on the probe or the lot number on the packaging to determine if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 42 days after the firm started it.

Apr 30, 2025Firm started the recall
Jun 4, 2025FDA classified it Class II
Jun 11, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52364-beckman-coulter-sample-probe-recall-defective-probe-mixes-sample-water">Beckman Coulter Sample Probe Recall: Defective Probe Mixes Sample Water (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1907-2025 (April 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1907-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.