Recall Z-1908-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Mishima K.K.
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
| Date | Jun 4, 2025 (initiated Apr 30, 2025) |
| Status | Completed |
| Reason | 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 | 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. |
| Quantity | 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 coun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961274 | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Jul 5, 1996 |