Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Recall
- Recall Number
- Z-1908-2025
- Event Number
- 96748
- Firm
- Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan
- FEI Number
- 3002807663
- Product Code
- JJE
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 30, 2025
- Posted
- June 4, 2025
Description
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
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.
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.
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
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