BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1798-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1798-2018
    Event ID
    79645
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Inpeco S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    February 13, 2018
    Classification Date
    May 10, 2018
    Termination Date
    April 3, 2019
    Address
    Via San Gottardo 10, N/A, Lugano, N/A, N/A, Switzerland

    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.

    Code Info

    Serial Numbers: Accelerator a3600 - ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214 FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181 Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095 Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers

    Distribution

    Distributors in 2 states: NY and IL.

    Quantity

    18