Skip to content

MicroScan V5.03 PU11Recalls & reported problems

Beckman Coulter, Inc. · MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K201405); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 26, 2026Open, Classified

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

    Z-2889-2026 · Root cause: Software Design Change · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201405. One submission often covers many models, so check the product and lot details in each record.

  • Z-2888-2026 · Jun 26, 2026 · Open, Classified
    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 Wa

Other System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices

All System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.