FDA recall, , Moderate risk
Beckman Coulter DxH Diluent and DxH ECO Diluent
Coulter DxH Diluent and ECO Diluent can cause elevated platelet background counts with use.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc., of Miami, Florida, recalled specific lots of COULTER DxH Diluent, REF 628017, and COULTER DxH ECO Diluent, REF C67250, because the diluents contributed to elevated platelet Daily Checks background counts when used with analyzers. The recall began November 10, 2025, and the FDA added it to its Enforcement Report on January 30, 2026.
The products are used as an isotonic buffered diluent with a cyanide-free lytic agent for counting and sizing blood cells on UniCel DxH Coulter Cellular Analysis Systems, as a rinsing agent on UniCel DxH Slidemaker Stainers, and as a diluent with DxH ECO Cell Lyse. Distribution was worldwide, including nationwide in the U.S. and in Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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.
- UDI-DI
- 15099590233686
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.
- Company
- Beckman Coulter, Inc.Miami, Florida
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97992
- Recall number
- Z-1221-2026
- Quantity recalled
- 76,098 units (US-61843 and OUS-14255)
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
