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Beckman Coulter Inc. recalls Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution t
Recalled September 24, 2014 · FDA recall Z-2651-2014 · Beckman Coulter
Hazard
Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. · FDA Class II
Units
46,050 units total (40,078 units in US)
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .
Description
Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
Product
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →