BEUDAMED
    FDA Recall Terminated

    Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

    Recall: Z-1733-2011 · Initiated March 23, 2010

    Recall

    Recall Number
    Z-1733-2011
    Event Number
    55146
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    March 23, 2010
    Posted
    March 18, 2011
    Terminated
    March 18, 2011
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

    Reason

    Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.

    Action

    The firm, Abbott, sent two "Product Correction" letters one dated March 23,2010 and a follow-up letter dated July 1, 2010, via express mail to all its consignees/customers. The letters described the product, problem and actions to be taken. The customers were instructed to perform the following steps, noted in the letter, to print and verify their gain setting. Abbott informed the customers that they would receive a mandatory software update and were instructed to install the CELL-DYN Emerald according to the attached instructions, and to complete and return the Customer Reply form via fax to 1-800-777-0051 or email to [email protected]. Should you have any questions or would like to discuss in more detail, contact Director Quality Assurance and Regulatory Affairs Abbott Hematology at 408-567-3403.

    Distribution

    Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, and WV; and countries including: Australia, Brazil, Canada, Columbia, Dominican Republic, Germany, Puerto Rico, Singapore, South Korea, St. Eustalius & St. Martin, and Turks & Caicos.

    Quantity

    891 units