COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
FDA Recall Z-2138-2023 · Posted 2023-07-12
Recalling FirmBeckman Coulter, Inc.
Recall StatusOpen, Classified
Product CodeGIF
Date Initiated2023-05-31
Product Quantity335, 448 units
Reason for Recall
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Firm Action
Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice on 05/31/2023 by email and mail. The notice explained the issue, its impact on the patient, and requested the following actions be taken:
"Inspect the lot number set up on your instrument(s) and your current inventory with the
corresponding container number (see Appendix A).
Locate the container number on your diluent reagent 2D or Linear barcode label (see
Appendix B).
Contact Beckman Coulter Customer Technical Support Organization to replace the
affected containers in your current inventory.
Consult with your laboratory management to determine whether a retrospective review
of results is necessary.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.