FDA Closes Recall of Beckman Coulter MicroScan Software Update
The agency considers the recall carried out for MicroScan LabPro V5.03 Panel Update 11 DVD Kits.
2 reports on this incident · first at Aug 18, 2026, 4:30 a.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
We last searched for new coverage of this at Aug 18, 2026, 1:37 a.m. ET — checked 8h ago.
Earlier reports
Aug 18, 2026, 4:30 a.m. ETFirst report
FDA Enforcement Report Details Class II Recall of Beckman Coulter MicroScan Software
On August 12, 2026, an FDA enforcement report published details regarding an ongoing Class II recall initiated on June 26, 2026, by Beckman Coulter Inc. The action, listed under recall number Z-2889-2026, affects REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US), with identifying UDI code 15099590799250/ V5.03 Panel Update 11.
According to the FDA report, the recall was initiated because analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications. The software is used on the 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, and B1018-496 DxM-1096 MicroScan WalkAway Instrument. Nationwide US distribution includes 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, and WY.
Class II is the FDA's middle category, defined by the agency as used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA database records document no other enforcement actions for this firm. The status of the recall remains ongoing and developing.
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Revision history
- Version 118 Aug 2026, 08:30current
First published.
- Version 118 Aug 2026, 08:56current
First published.
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