BEUDAMED
    FDA Enforcement Class III Ongoing

    RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578

    Recall: Z-1695-2023 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1695-2023
    Event ID
    92276
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mechatronics USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 14, 2023
    Initiation Date
    April 14, 2023
    Classification Date
    June 7, 2023
    Address
    20 Altieri Way Unit 4, Warwick, RI, 02886-1761, United States

    Description

    RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578

    Reason

    QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.

    Code Info

    UDI: (01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp. Date: QCAB6AAA28 24-02-2022

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of OH and the country of Netherlands.

    Quantity

    10752 units