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Use caution Medical device recall · FDA · Published January 30, 2026

Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk

Beckman Coulter recalls AU5800 chemistry analyzers with specific serial numbers that may cause delays in results due to software errors after 15 minutes of calibration monitor use. Affected units require service to fix.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1553-2026Medical deviceBeckman Coulter ›
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Contact the company

Recalling firmBeckman Coulter Mishima K.K.454-32, Higashino; Nagaizumi-Cho · Sunto-Gun, Japan
✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling certain AU5800 chemistry analyzers that may cause delays in test results if the calibration monitor is left open for more than 15 minutes. This could lead to errors in patient testing and treatment delays. Read more at govinfonow.com/recall/50062-beckman-coulter-au5800-chemistry-analyzer-recall-delay-in-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/50062-beckman-coulter-au5800-chemistry-analyzer-recall-delay-in-results-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1553-2026

Cite this page

“Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50062-beckman-coulter-au5800-chemistry-analyzer-recall-delay-in-results-risk. Based on FDA recall #Z-1553-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1553-2026%22&limit=1).

Beckman Coulter Mishima K.K. recalled CHEMISTRY ANALYZER AU5800 units nationwide due to a hazard that may delay diagnosis and patient treatment, the FDA said on Jan. 30, 2026.

How to tell if you have it

  • Brand: Beckman Coulter
  • Product: CHEMISTRY ANALYZER AU5800
  • REF codes: B96697, B96698, B23279, B23280, B23281
  • Units affected: 47

The hazard

A delay in results may occur when the clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond 15 minutes. This condition may lead to Reagent Blank and calibration databases not opening errors, causing the system to stop analyzing until firm service applies a software solution.

Context

GovInfoNow's records show Beckman Coulter Mishima K.K. has 4 other recalls on record since June 5, 2024. Other recent recalls of similar products include Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 (Aug. 3, 2026), Beckman Coulter Sample Probes May Cause False Low Test Results (April 30, 2025), and Beckman Coulter DxC 500 AU Analyzer Recall: Software Error Causes Delayed Results (July 10, 2024). Other recent recalls of similar products include Beckman Coulter UniCel Dxl 600: May not restart after shutdown causing delayed test results (Nov. 26, 2025), Beckman Coulter UniCel Dxl 800 May Not Restart After Shutdown (Nov. 26, 2025), and Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026).

How to tell if you have this one

Check for serial numbers B96697, B96698, B23279, B23280, or B23281 on the analyzer. Newer models installed with PC preloaded with Microsoft SQL Server 2022 Express from 2025061442 to 2025121623 are affected. Older models replaced with this software are also included.

  • 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 NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.
Recall numberProduct, codes & lotsQuantity
Z-1552-2026DxC 700 AU, REF: B86444, B86446; REF/UDI-DI/Serial Numbers: Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B86444/14987666542545/2025060063, 2025060073, 2025060074, 2025060075, 2025060079, 2025060085, 2025060086, 2025060087, 2025060091, 2025060098, 2025060099, 2025060124, 2025060125, 2025060126, 2025060127, 2025060128, 2025060129, 2025070139, 2025070156, 2025070159, 2025070160, 2025070161, 2025070164, 2025070167, 2025070168, 2025070169, 2025070178, 2025070180, 2025070181, 2025070182, 2025070184, 2025070186, 2025070191, 2025070192, 2025070193, 2025070194, 2025070204, 2025080208, 2025080217, 2025080219, 2025080236, 2025080237, 2025080238, 2025080241, 2025080242, 2025080246, 2025080247, 2025080250, 2025090266, 2025090267, 2025090270, 2025090271, 2025090273, 2025090274, 2025090275, 2025090281, 2025090283, 2025090285, 2025090286, 2025090287, 2025090289, 2025090290, 2025090291, 2025090292, 2025090293, 2025090294, 2025090295, 2025090296, 2025090297, 2025090298, 2025090299, 2025090301, 2025090302, 2025090303, 2025090304, 2025090306, 2025100370, 2025100371, 2025100372, 2025100373, 2025100421, 2025100422, 2025100423, 2025100424, 2025100425, 2025100426, 2025100427, 2025110428, 2025110429, 2025110437, 2025110442, 2025110445, 2025110452, 2025110454, 2025110456, 2025110457, 2025110458, 2025110462, 2025120464, 2025120468, 2025120469, 2025120471, 2025120475, 2025120477, 2025120478, 2025120479, 2025120480, 2025120482, 2025120483, 2025120484, 2025120485, 2025120486, 2025120487, 2025120488, 2025120489, 2025120490, 2025120492, 2025120493, 2025120494, 2025120495, 2025120496. B86446/14987666542514/2025090277, 2025090284. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B86444/14987666542545/2017050064, 2017100174, 2018030312, 2018040352, 2018100561, 2018110599, 2019010712, 2019010713, 2019111170, 2021021852, 2021102318, 2021122458, 2022042631, 2022052705, 2022062775, 2023063701, 2024064408, 2024064419, 2024064440142
Z-1553-2026CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281; REF/UDI-DI/ Newer Instrument Installed with PC preinstalled with Microsoft SQL Server 2022 Express: B96697/14987666543016/2025061442, 2025061446, 2025061452, 2025061454, 2025061464, 2025071479, 2025071488, 2025081513, 2025081516, 2025091536, 2025091538, 2025091543, 2025091559, 2025091561, 2025111598, 2025111602, 2025111604, 2025111605, 2025111606, 2025121618, 2025121622, 2025121623. B96698/14987666543023/2025061449, 2025061451, 2025061457, 2025061467, 2025071475, 2025071476, 2025071478, 2025071481, 2025071495, 2025071497, 2025081503, 2025081524, 2025091539, 2025091549, 2025091551. Older Instrument Replaced with PC preinstalled with Microsoft SQL Server 2022 Express: B23279/14987666541296/2014011316, 2014071647, 2014121858, 2014121906. B23280/14987666541302/2016022593. B23281/14987666541319/5094354. B96697/14987666543016/2019074683. B96698/14987666543023/2017063377, 2019114891, 202410128847
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Identify if your AU5800 has a serial number from the list: B96697, B96698, B23279, B23280, or B23281.

  2. Contact Manufacturer

    Reach out to Beckman Coulter for service if your unit is affected, as they will need to fix the software issue.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 35 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: 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: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

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

1. Firm started the recall: Jan 30, 202612. FDA classified it Class II: Mar 11, 202623. Published in FDA’s Enforcement Report: Mar 18, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1553-2026 (January 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1553-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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