BEUDAMED
    FDA Recall Terminated

    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).

    Recall: Z-1234-2014 · Initiated February 21, 2014

    Recall

    Recall Number
    Z-1234-2014
    Event Number
    67584
    Firm
    Medical Information Technology, Inc.
    FEI Number
    3009404844
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 21, 2014
    Posted
    March 19, 2014
    Terminated
    November 12, 2015
    Address
    7 Blue Hill River Rd, Canton, MA, 02021-1001

    Description

    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).

    Reason

    Potential for erroneous result reporting.

    Action

    Beginning on February 3, 2014 MEDITECH distributed a notification to Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. The issue will be corrected by CS LAB DTS 12279.

    Distribution

    Distributed USA (nationwide) and Canada.

    Quantity

    438