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Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Recalled July 19, 2023 · FDA recall Z-2138-2023 · Beckman Coulter
Hazard
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. · FDA Class II
Units
335, 448 units
Sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia (Plurinational State of), Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Viet Nam.
Description
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Product
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →