FDA recall Z-2138-2023

Product

COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

Reason for recall

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-05-31

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2023