FDA-Device2026-02-11Class IIPROCESSING DEFECT
Beckman Coulter COULTER DxH Diluent recalled for inaccurate platelet test results
OTHERNationwide distribution
Stop using recalled Beckman Coulter diluent lots
Beckman Coulter has recalled specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent used in blood cell analysis systems. These affected lots can produce inaccurate platelet count readings during daily quality checks, which may lead to unreliable test results.
- Check if your COULTER DxH or DxH ECO analyzer uses diluent lot numbers 2510410, 2510420, 2510450, 3557500–3557710, 3557850, 3557920–3557930, 3558000–3558170
- Stop using affected lots immediately
- Contact Beckman Coulter or your supplier for replacement diluent and instructions
- Review any patient test results from affected lots with your laboratory director
Hazard
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Sold states
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, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.
Affected count
76,098 units (US-61843 and OUS-14255)
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1221-2026More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
- FDA-Device2026-04-15MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- FDA-Device2026-04-01Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
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