FDA-Device2023-07-19Class II
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
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-2138-2023More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
- FDA-Device2026-04-15MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- FDA-Device2026-04-01Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
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