BEUDAMED
    FDA Recall Terminated

    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

    Recall: Z-1798-2018 · Initiated February 13, 2018

    Recall

    Recall Number
    Z-1798-2018
    Event Number
    79645
    Firm
    Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
    FEI Number
    3010825766
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 13, 2018
    Terminated
    April 3, 2019

    Description

    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

    Reason

    Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.

    Action

    On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, [email protected], (+41) 91 9118 258.

    Distribution

    Distributors in 2 states: NY and IL.

    Quantity

    18