BEUDAMED
    FDA Enforcement Class II Terminated

    NucliSENS Lysis Buffer Extended lot for RES 76675

    Recall: Z-0086-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0086-2018
    Event ID
    78387
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2017
    Initiation Date
    October 18, 2017
    Classification Date
    November 9, 2017
    Termination Date
    August 24, 2021
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    NucliSENS Lysis Buffer Extended lot for RES 76675

    Reason

    Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.

    Code Info

    REF 200292, Lot 17022802, Exp Date 01/28/2019 Extended lot for RES 76675

    Distribution

    Distributed domestically to MD, CO, and OH.

    Quantity

    911 units