—#217394

Product

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.

FDA product code: GIF — Diluent, Blood Cell
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: Catalog Numbers: COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 UDI-DI code: 15099590233686 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

Why it was recalled

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

During the week of 11/10/2025, the firm sent via postal and e-mail an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter has confirmed that specific diluent lot numbers of COULTER DxH Diluent and DxH ECO Diluent may contribute to elevated platelet (PLT) Daily Checks background counts cycle when used with the UniCel DxH 600/690T/800/900 analyzers. Customers are instructed to: "Check their COULTER DxH Diluent and DxH ECO Diluent inventory against the provided affected lot numbers. "If their lot numbers are NOT affected, continue routine operation and no further action is required. "If their lot numbers are affected, perform a Daily Checks cycle. o Each container must be individually verified through Daily Checks before use according to the instructions below. o If Daily Checks pass, continue routine operation and no further action is required, on the active diluent container(s), currently in use. "If the Daily Checks cycle does not pass, follow the instruction provide in the Recall Letter. For questions or further assistance - email BECFA@beckman.com

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-11-10
Posted by FDA: 2026-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217394. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.