BEUDAMED
    FDA Enforcement Class II Terminated

    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

    Recall: Z-1158-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1158-2020
    Event ID
    84697
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 7, 2020
    Classification Date
    February 12, 2020
    Termination Date
    October 15, 2020
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

    Reason

    Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

    Code Info

    All cobas infinity laboratory solution software versions are affected.

    Distribution

    Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

    Quantity

    26 accounts