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Lower risk Medical device recall · FDA · Published June 26, 2026

Beckman Coulter MicroScan LabPro V5.03 Panel Update 11: Incorrect Algorithms May Affect

Beckman Coulter recalls MicroScan LabPro V5.03 Panel Update 11 (US) electronic updates that may cause false antimicrobial susceptibility test results. Affected instruments include MicroScan autoSCAN-4, WalkAway-40 plus, WalkAway-96 plus, and DxM-1040/DxM-1096 models.

🇺🇸 FDA recall #Z-2888-2026Medical deviceBeckman Coulter ›
✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 electronic updates that could lead to false antimicrobial test results. This affects specific laboratory instruments used for testing bacterial resistance. Users should check if their instrument matches the listed models and serial numbers to determine if they are affected. Read more at govinfonow.com/recall/314304-beckman-coulter-microscan-labpro-v5-03-panel-update-11-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/314304-beckman-coulter-microscan-labpro-v5-03-panel-update-11-incorrect · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2888-2026

Cite this page

“Beckman Coulter MicroScan LabPro V5.03 Panel Update 11: Incorrect Algorithms May Affect.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314304-beckman-coulter-microscan-labpro-v5-03-panel-update-11-incorrect. Based on FDA recall #Z-2888-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2888-2026%22&limit=1).

The FDA announced on June 26, 2026, that Beckman Coulter Inc. is recalling REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), installed on 158 instruments nationwide due to incorrect algorithms that may affect antimicrobial susceptibility test results.

How to tell if you have it

  • REF # D23352
  • MicroScan LabPro V5.03 Panel Update 11 (US)
  • 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

The hazard

According to the FDA, the analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026), and Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (December 23, 2025). Other recent recalls of similar products include Beckman Coulter REMISOL Advance Software Issue: Incorrect Test Results Results (April 29, 2026), Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (January 30, 2026), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (January 5, 2026).

How to tell if you have this one

Check if your MicroScan instrument has the model numbers listed: B1018-280 (autoSCAN-4), B1018-283 (WalkAway-40 plus), B1018-284 (WalkAway-96 plus), B1018-440 (DxM-1040), or B1018-496 (DxM-1096). The UDI number 15099590799243 indicates the specific version.

  • Brand
    Beckman Coulter
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution including in 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 numberProduct, codes & lotsQuantity
Z-2888-2026REF # 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; UDI: 15099590799243/ V5.03 Panel Update 11158 instruments
Z-2889-2026REF # 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 WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument; UDI: 15099590799250/ V5.03 Panel Update 11—
Based on the official FDA remedy

What to do — step by step

  1. Check Instrument Model

    Identify your MicroScan instrument model from the list: B1018-280, B1018-283, B1018-284, B1018-440, or B1018-496.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 37 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Jun 26, 202612. FDA classified it Class II: Aug 5, 202623. Published in FDA’s Enforcement Report: Aug 12, 202634. Added to GovInfoNow: Aug 18, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2888-2026 (June 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2888-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA