The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2888-2026·Announced 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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device (Class II) with a theoretical risk of producing false susceptibility classifications, making it a risk-of-harm product where no injuries or illnesses have been reported yet. Per the rubric, this qualifies as a High severity item because it is a risk-of-harm product without documented harm.

Plain-English summary

The U.S. Food and Drug Administration is recalling REF # D23352, MicroScan LabPro V5.03 Panel Update 11 electronic analyzers manufactured by Beckman Coulter Inc. These instruments, distributed nationwide across 50 U.S. states, include models such as B1018-280, B1018-283, B1018-284, B1018-440, and B1018-496. The recall is due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.

All users of these 158 instruments are affected, as the faulty algorithms could compromise the reliability of antimicrobial resistance testing. Consumers should stop using the affected analyzers immediately and follow guidance from Beckman Coulter Inc. regarding corrective actions, such as obtaining updated software or firmware. Healthcare providers relying on these instruments for patient care should verify results and consider alternative testing methods while awaiting resolution.

The recall falls under FDA Class II classification, indicating a moderate risk of harm. While no deaths or serious injuries have been reported, the potential for incorrect diagnostic results places this in the High severity category per the rubric, as it represents a risk-of-harm product where injury has not yet been confirmed.

The recalled product

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…
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Lab Analysis Instruments
Hazard
Affected units
158

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: 15099590799243/ 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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