The Recall Desk

FDA (Devices) recall action 99349

Beckman Coulter Inc. recalled 2 products on 2026-08-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-08-12
Critical
0
Units
158

Why these products were recalled

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2026-08-12

    Beckman Coulter MicroScan Panel Update DVD Kits Recalled

    Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 DVD Kits due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.

    Product
    REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) 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 Walk
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2026-08-12

    MicroScan LabPro V5.03 Panel Update 11 analyzers recalled for incorrect algorithms affecting test results

    The FDA is recalling MicroScan LabPro V5.03 Panel Update 11 electronic analyzers because their algorithms may produce inaccurate antimicrobial susceptibility test results.

    Product
    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
    Category
    Distribution
    37 states