BEUDAMED
    FDA Enforcement Class II Terminated

    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

    Recall: Z-0097-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0097-2023
    Event ID
    90885
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 8, 2022
    Classification Date
    October 17, 2022
    Termination Date
    November 7, 2024
    Address
    1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

    Reason

    Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.

    Code Info

    Device Identifier: 07613336170076 All serial IDs are affected.

    Distribution

    International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.

    Quantity

    179 OUS