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Lower risk Medical device recall · FDA · Published June 20, 2017

Beckman Coulter UniCel DxH Slidemaker Stainer Software 3.2 Recall: Fitting May Not Seal

Beckman Coulter recalls UniCel DxH Slidemaker Stainer software version 3.2 due to potential leakage from a fitting that may not seal after installation. This affects blood analysis systems used in labs.

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Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
✎ GovInfoNow plain-language explainer

What happened, in plain English

Beckman Coulter is recalling software version 3.2 for their UniCel DxH Slidemaker Stainer system because a fitting might not seal properly after installation. This could lead to leaks in blood samples during analysis, which might affect test accuracy. Read more at govinfonow.com/recall/73824-beckman-coulter-unicel-dxh-slidemaker-stainer-software-3-2-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/73824-beckman-coulter-unicel-dxh-slidemaker-stainer-software-3-2-recall · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3101-2017

Cite this page

“Beckman Coulter UniCel DxH Slidemaker Stainer Software 3.2 Recall: Fitting May Not Seal.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73824-beckman-coulter-unicel-dxh-slidemaker-stainer-software-3-2-recall. Based on FDA recall #Z-3101-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3101-2017%22&limit=1).

Why it’s dangerous

The fitting in some units may not seal completely after installation, potentially allowing leaks in blood samples. This could lead to inaccurate blood test results if samples are contaminated or spilled.

Who’s affected

Lab technicians and medical professionals who use the UniCel DxH Slidemaker Stainer system with software version 3.2 are most at risk. The recall affects blood analysis equipment used in clinical settings.

How to tell if you have this one

Check for the product name 'UniCel DxH Slidemaker Stainer' with software version 3.2. The part number is A85371AA20 and catalog number 775222.

  • Brand
    Beckman Coul: A short, human brand name for headings (e.g.
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your device; if it's 3.2, it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth 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: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: 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: nationwideOKLouisiana: 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 noticeFL

FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

1. Firm started the recall: Jun 20, 201712. FDA classified it Class II: Sep 1, 201723. Published in FDA’s Enforcement Report: Sep 6, 201734. FDA terminated the recall: Apr 21, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-3101-2017 (June 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3101-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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