BEUDAMED
    FDA Recall Terminated

    Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.

    Recall: Z-0619-03 · Initiated January 27, 2003

    Recall

    Recall Number
    Z-0619-03
    Event Number
    25482
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2003
    Posted
    March 6, 2003
    Terminated
    October 8, 2003
    Address
    200 South Kraemer Blvd W, 337, Brea, CA, 92822

    Description

    Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.

    Reason

    Spring failure, design defect in component.

    Action

    A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment)

    Distribution

    Product has been distributed in US from 8/92 to present. All these units are affected.

    Quantity

    2418