BEUDAMED
    FDA Recall 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 · Initiated September 8, 2022

    Recall

    Recall Number
    Z-0097-2023
    Event Number
    90885
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    NSU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 8, 2022
    Posted
    October 17, 2022
    Terminated
    November 7, 2024
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    On September 8, 2022, the firm notified all affected customers via an Urgent Field Safety Notice letter. Customers were informed that the issue was attributed to WAKO lenses with a deposit on their surfaces, which can affect the signal in the detection unit. Roche will retrieve and analyze customer's cobas 5800 run data. If the evaluation determines that a lens cleaning is warranted, a service visit will be scheduled. If a lens cleaning is not warranted, no further actions are required. Customers should follow laboratory standard operating procedures to investigate the potential for false positive results for assays where a change in result reporting could impact patient management. In the case of testing for respiratory viruses or blood screening, uncovering false positive results more than one week old would be unlikely to change patient management. In the case of assays used to manage chronic diseases (e.g. hepatitis C) or those used in serial monitoring (e.g. HIV), only the most recent result for a patient would have the potential to affect management. Contact your local affiliate organization if there is any allegation of invalid or false positive results with the cobas 5800 system assays. This device is not currently available in the US.

    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