BEUDAMED
    FDA Recall Terminated

    OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D

    Recall: Z-1161-06 · Initiated March 28, 2006

    Recall

    Recall Number
    Z-1161-06
    Event Number
    35518
    Firm
    bioMerieux Inc
    FEI Number
    1950204
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2006
    Posted
    June 22, 2006
    Terminated
    March 7, 2008
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D

    Reason

    Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's

    Action

    The recalling firm telephoned customers who ordered the MB bottles and use the OBSERVA software ver. 2.0 to inform them of the issues. Recall letters were issued to all customers via overnight mail on 5/22/06 informing them a field representative would be visiting to make a short-term correction to the system. The letter also informed the customer a permanent correction to the software was scheduled for release later in the year.

    Distribution

    WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherlands, Germany, Greece, Portugal, and France.

    Quantity

    51 units