BEUDAMED
    FDA Enforcement Class II Terminated

    cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

    Recall: Z-2444-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2444-2021
    Event ID
    88398
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    June 24, 2021
    Classification Date
    September 10, 2021
    Termination Date
    July 21, 2023
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

    Reason

    Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.

    Code Info

    UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08

    Distribution

    US Nationwide distribution

    Quantity

    2058 licenses worldwide, 79 licenses in US