United StatesCOULTER DxH Diluent (REF 628017) and COULTER DxH ECO Diluent (REF C67250), UDI‑DI 15099590233686, lots 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 are affected. Specific lots were recalled because they contributed to elevated platelet Daily Checks background counts when used with UniCel DxH Coulter Cellular Analysis Systems and related equipment; the product was distributed worldwide, including the listed U.S. states and several other countries.
What's being recalled
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.
Recalling firm: Beckman Coulter, Inc., Miami, FL, United States.
How to identify it
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
The hazard
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada