Class 2 Device Recall Sample probe (S probe)

• Date Initiated by Firm: April 30, 2025
• Date Posted: June 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1907-2025
• Recall Event ID: 96748
• 510(K)Number: K981743
• Product Classification: Acid phosphatase, naphthyl phosphate - Product Code CKB
• Product: Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
• Code Information: 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
• FEI Number: 3002807663
• Recalling Firm/ Manufacturer: Beckman Coulter Mishima K.K.; 454-32; Higashino; Nagaizumi-Cho; Sunto-Gun Japan
• Manufacturer 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.
• FDA Determined 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 beckmanresponse@abcoinc.com -Complete and return the Replacement Order Form to askbeckman@beckman.com 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 askbeckman@beckman.com or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821.
• Quantity in Commerce: 10,176
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CKB