The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2889-2026·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. The incorrect algorithms in antimicrobial susceptibility testing could lead to false susceptibility classifications, which poses a risk to patient care by potentially resulting in inappropriate antibiotic treatment decisions. The nationwide distribution to healthcare facilities increases the potential impact.

Plain-English summary

Beckman Coulter Inc. is recalling REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kits distributed nationwide in the United States. The recall affects kits used with several MicroScan instruments including the autoSCAN-4, WalkAway-40 plus, WalkAway-96 plus, DxM-1040, and DxM-1096 systems.

The recalled products contain incorrect algorithms that may affect antimicrobial susceptibility test results. This could lead to false susceptibility classifications, which may impact the accuracy of tests used to determine appropriate antibiotic treatments for infections.

The recall affects healthcare facilities and laboratories across the United States, including those in Alaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia, and Wyoming.

Healthcare facilities and laboratories using the affected MicroScan systems should contact Beckman Coulter Inc. for replacement kits and instructions on how to address any test results generated while using the affected software update.

The recalled product

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…
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Antimicrobial Susceptibility Testing
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 15099590799250/ V5.03 Panel Update 11

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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