BEUDAMED
    FDA Enforcement Class II Terminated

    Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

    Recall: Z-0669-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0669-2020
    Event ID
    84260
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    October 28, 2019
    Classification Date
    December 12, 2019
    Termination Date
    June 28, 2022
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

    Reason

    Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).

    Code Info

    Anti-HAV IgM APP-file (version 06.05-101)

    Distribution

    US Nationwide distribution.

    Quantity

    712 units