BEUDAMED
    FDA Recall Terminated

    Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01

    Recall: Z-0246-2007 · Initiated September 18, 2006

    Recall

    Recall Number
    Z-0246-2007
    Event Number
    36567
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    KRY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 18, 2006
    Posted
    December 5, 2006
    Terminated
    November 28, 2007
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01

    Reason

    Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

    Action

    The firm notified its consignees via customer letter sent on 09/18/2006, with information regarding the recall, requesting reply via a form included in the letter.

    Distribution

    Worldwide, including USA, Costa Rica, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, El Salvador, Germany, Japan, Philippines, Singapore, Hong Kong/China, Taiwan, Thailand, Malaysia, South Korea, Australia, New Zealand, Honduras, Nicaragua, Haiti, Bermuda, Virgin Islands, Panama, St. Eustatius, and St. Martin.

    Quantity

    4708 units