FDA-Device2023-07-19Class II
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Beckman Coulter, Inc.
Hazard
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Sold states
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.
Affected count
335, 448 units
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2023Don't want to check this manually?
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