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Lower risk Medical device recall · FDA · Published November 10, 2025

Beckman Coulter DxH Diluent Recall: Elevated Platelet Counts Risk

Beckman Coulter recalls specific lots of DxH Diluent (REF 628017 and C67250) that may cause elevated platelet counts in blood tests. Affected units include certain lot numbers for use with UniCel DxH analyzers.

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

🇺🇸 FDA recall #Z-1221-2026Medical deviceBeckman Coulter ›
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Contact the company

Recalling firmBeckman Coulter, Inc.11800 Sw 147th Ave · Miami, FL 33196-2500
✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling specific lots of DxH Diluent products that may cause elevated platelet counts in blood tests. This could lead to inaccurate blood cell counts if used with certain analyzers. Read more at govinfonow.com/recall/50695-beckman-coulter-dxh-diluent-recall-elevated-platelet-counts-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/50695-beckman-coulter-dxh-diluent-recall-elevated-platelet-counts-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1221-2026

Cite this page

“Beckman Coulter DxH Diluent Recall: Elevated Platelet Counts Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50695-beckman-coulter-dxh-diluent-recall-elevated-platelet-counts-risk. Based on FDA recall #Z-1221-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1221-2026%22&limit=1).

The FDA announced on Nov. 10, 2025, that Beckman Coulter is recalling COULTER DxH Diluent and COULTER DxH ECO Diluent due to elevated platelet background counts. The agency issued recall number Z-1221-2026 for the Class II voluntary recall.

How to tell if you have it

  • COULTER DxH Diluent, REF 628017
  • COULTER DxH ECO Diluent REF C67250
  • Lot Numbers: 2510410, 2510420, 2510450, 3557500, 3557510, 3557540, 3557560, 3557570, 3557640, 3557650, 3557660, 3557670, 3557680, 3557700, 3557710, 3557850, 3557920, 3557930, 3558000, 3558030, 3558040, 3558060, 3558090, 3558100, 3558110, 3558120, 3558140, 3558150, 3558160, 3558170
  • Worldwide distribution including U.S. states AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and countries Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, Viet Nam

The hazard

The FDA stated that specific lots of the diluents contribute to elevated platelet Daily Checks background counts cycle with use with analyzers.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since 2017-06-20. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 (2026-07-15), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (2026-06-26), and Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16). Additional similar recalls include Beckman Coulter Bicarbonate Reagent (2025-10-14), Beckman Coulter LDL Cholesterol Reagent (2025-12-08), and Beckman Coulter Emit 2000 Quinidine Assay (2026-07-13).

How to tell if you have this one

Check for product labels with catalog numbers COULTER DxH Diluent REF 628017 or COULTER DxH ECO Diluent REF C67250. Affected lots include 2510410, 2510420, and other specific numbers listed in the recall notice.

  • Brand
    Beckman Coulter
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Numbers

    Look for lot numbers on the product label such as 2510410, 2510420, or others listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth 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: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: 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: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: 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 noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Nov 10, 202512. FDA classified it Class II: Jan 30, 202623. Published in FDA’s Enforcement Report: Feb 11, 2026320252026
  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-1221-2026 (November 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1221-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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