Z-1908-2025Class II

Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a...

Name: Z-1908-2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a...
Creator: Beckman Coulter Mishima K.K.
Published: 2025-04-30
License: https://open.fda.gov/license/

Beckman Coulter Mishima K.K. / initiated 2025-04-30 / Completed / root cause: manufacturing process

FDA source

Beckman Coulter Mishima K.K. began a recall of Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670 on 2025-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1908-2025
Classification: Class II
Status: Completed
Initiated: 2025-04-30
Posted: 2025-06-04
Recalling firm: Beckman Coulter Mishima K.K.
Product: Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An "URGENT MEDICAL DEVICE RECALL" dated 4/24/2025 were mailed and emailed to customers on 4/30/2025 who were asked to do the following: - Check the analyzers, which meet the conditions below: a) Analyzers whose Serial No. is from 2023070718 to 2025021482. b) Analyzers whose sample probe has been replaced since July 1, 2023. - For analyzers that meet either of the above criteria, remove the sample probe from the instrument in accordance with IFU Section 6, Maintenance / As needed Maintenance/Replace a Sample or Reagent Probe. And then, check the groove on the head of the removed sample probe. a) If it has a marking line, continue to use. b) If it does not have a marking line, replace the sample probe with a probe not included in the impacted sample probe lot numbers. - Dispose impacted probes to ensure it is not used. Also check the sample probes included in the maintenance kits. Contact your firm representative for replacements. - If all the results of the actions above show only defective sample probes on your analyzers and in stock, stop measuring the assay items which sample volume is 2.0 microliters or less and contact your BEC representative for a replacement. - Firm recommends that customers should share the content of this letter with their laboratory and/or medical director to assess if a retrospective review of the patient results is needed. - Complete and return the response form via email to [email protected] -Complete and return the Replacement Order Form to [email protected] or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821 If you have any questions regarding this notice, please contact the firm's Customer Support Center: From firm website: http://www.beckmancoulter.com For customers in the United States, if you need replacement product: Complete Replacement Order Form and email to [email protected] or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1908-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1907-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-11	2025-06-04
Z-1908-2025	Class II	Completed	Voluntary: Firm initiated	2025-06-11	2025-06-04

Product code JJE

K961274Class IOlympus Au600 Clinical Chemistry AnalyzerOlympus America, Inc. / cleared 1996-07-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)