Beckman Coulter MicroScan LabPro V5.03 Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Beckman Coulter Inc. is recalling 158 MicroScan instruments with LabPro V5.03 Panel Update 11 due to incorrect algorithms that may cause false susceptibility classifications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.

What Happened

Beckman Coulter Inc. initiated a recall of certain MicroScan instruments because the analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.

Which Products Are Affected

The recall involves 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 MicroScan WalkAway Instrument
  • B1018-496 DxM-1096 MicroScan WalkAway Instrument

A total of 158 instruments are affected. The UDI is 15099590799243/ V5.03 Panel Update 11. Distribution was nationwide in the United States, including the states of 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, WY. Recall number Z-2888-2026. Classification: Class II.

What You Should Do

No specific consumer action steps or contact information for returns or refunds are provided in the recall notice.

Why This Matters

The recall affects 158 instruments distributed nationwide and involves potential inaccuracies in antimicrobial susceptibility test results.

Source

FDA Recall Z-2888-2026 - Beckman Coulter Inc., Brea, CA

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Beckman Coulter Inc. is recalling 158 MicroScan instruments with LabPro V5.03 Panel Update 11 due to incorrect algorithms that may cause false susceptibility classifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.