CanadaThe product affected is Coulter DxH Diluent (catalogue number 628017); Beckman Coulter has identified more than 10 affected lot or serial numbers, so contact the manufacturer to determine if your lot is included. Beckman Coulter confirmed those specific diluent lot numbers contribute to elevated platelet (PLT) Daily Checks background counts when used with UniCel DxH 600/690T/800/900 analyzers, causing PLT background counts ranging from 3.0 to 9.1 x 10^3 cells/µL; contact the manufacturer for additional information.
What's being recalled
Companies: Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, California, United States, 92821.
How to identify it
Affected products: Coulter DxH Diluent; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 628017
The hazard
Beckman Coulter has confirmed that specific diluent lot numbers of Coulter DxH Diluent contribute to elevated platelet (PLT) Daily Checks background counts cycle when used with the UniCel DxH 600/690T/800/900 analyzers. This may result in elevated PLT background counts in Daily Checks ranging from 3.0 to 9.1 x 103 cells/μL.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States