BEUDAMED
    FDA Enforcement Class II Terminated

    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system

    Recall: Z-2223-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2223-2017
    Event ID
    77243
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 14, 2017
    Initiation Date
    May 9, 2017
    Classification Date
    June 2, 2017
    Termination Date
    February 2, 2018
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system

    Reason

    a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. This issue can pose a potential risk to involved operators and can also lead to potential cross contamination of samples in the affected racks.

    Code Info

    Serial Number 204C5690 204H0157 204H0158

    Distribution

    US distribution to WA only.

    Quantity

    3