Recall Z-2888-2026 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Beckman Coulter Inc.
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
| Date | Aug 5, 2026 (initiated Jun 26, 2026) |
| Status | Open, Classified |
| Reason | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| Root cause | Software Design Change |
| Action | Between the dates of June 26 -29, 2026, Beckman Coulter issued a Urgent Medical Device via Email and US Mail. Beckman Coulter ask consignees to take the following actions: 1. Manually verify results from the panels and assays listed below for Daptomycin or Cefepime when read with the WalkAway instrument or autoSCAN-4 instrument and for Vancomycin when read with the autoSCAN-4 instrument. 2. Continue routine quality control procedures, review flagged or unusual panel results and follow laboratory verification practices prior to reporting results. 3. Beckman Coulter recommends sharing the co |
| Quantity | 158 instruments |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201405 | LabPro Data Management System Beckman Coulter, Inc., Aug 30, 2020 |