BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2138-2023 · Initiated May 31, 2023

    Recall

    Recall Number
    Z-2138-2023
    Event Number
    92419
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    GIF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 31, 2023
    Posted
    July 12, 2023
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500

    Description

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

    Reason

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

    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.

    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.

    Quantity

    335, 448 units