Beckman Coulter Recalls COULTER DxH Diluent Lots Due to Elevated Platelet Background Counts

What Happened

Beckman Coulter, Inc. has initiated a voluntary recall of specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent. The recall was triggered after it was determined that certain lots contribute to elevated platelet “Daily Checks” background counts when used with cellular analyzers. This issue was identified as a Class II recall by the FDA.

Which Products Are Affected

The recall affects approximately 76,098 units (61,843 in the U.S. and 14,255 internationally). The affected products are used as isotonic buffered diluents for counting and sizing blood cells on UniCel DxH Coulter Cellular Analysis Systems and as rinsing agents on Slidemaker Stainers.

Product Details:

• Product Names: COULTER DxH Diluent (REF 628017) and COULTER DxH ECO Diluent (REF C67250)
• UDI-DI Code: 15099590233686
• Recall Number: Z-1221-2026
• Affected 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.

Geographic Scope: Distribution was worldwide, including U.S. nationwide distribution in 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, and WV. International distribution included Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.

What You Should Do

Beckman Coulter, Inc. notified affected customers via letter starting November 10, 2025. Laboratories and healthcare facilities should immediately check their inventory for the affected lot numbers listed above. For information regarding the return or replacement of affected products, customers should contact Beckman Coulter, Inc. at their Miami facility located at 11800 Sw 147th Ave, Miami, FL 33196-2500.

Why This Matters

Elevated background counts during daily checks can interfere with the accuracy of blood cell counting and sizing. This defect may lead to unreliable diagnostic results when using UniCel DxH Coulter Cellular Analysis Systems.

Source

Information provided by the FDA.