Class 2 Device Recall COULTER DxH Diluent DxH ECO Diluent

• Date Initiated by Firm: November 10, 2025
• Date Posted: January 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1221-2026
• Recall Event ID: 97992
• Product Classification: Diluent, blood cell - Product Code GIF
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 11800 Sw 147th Ave; Miami FL 33196-2500
• For Additional Information Contact: Jennifer Chau; 305-380-4705
• Manufacturer Reason for Recall: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 76,098 units (US-61843 and OUS-14255)
• 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.