BEUDAMED
    FDA Recall Terminated

    FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.

    Recall: Z-0002-2008 · Initiated February 22, 2007

    Recall

    Recall Number
    Z-0002-2008
    Event Number
    38369
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    LXG
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 22, 2007
    Posted
    October 16, 2007
    Terminated
    April 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.

    Reason

    Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

    Action

    A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.

    Distribution

    Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.

    Quantity

    9 in the U.S.; 1 in Canada