BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 14, 2023

    Recall

    Recall Number
    Z-1695-2023
    Event Number
    92276
    Firm
    Mechatronics USA
    FEI Number
    3004016971
    Product Code
    GKB
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    April 14, 2023
    Posted
    June 7, 2023
    Address
    20 Altieri Way, Unit 4, Warwick, RI, 02886-1761

    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.

    Action

    Mechatronics issued Urgent Field Safety corrective action letter on 4/14/23 via email. Letter states reason for recall, health risk and action to take: Field Safety Field corrective action to be taken by the customer: 1. Confirm that you have received this information by returning enclosed acknowledgement form. 2. Please check your inventory for QRR049001-Starrsed Control Level N-Lot QCAB6AN505. 3. Please check your inventory for QRR049002-Starrsed Control Level A-Lot QCAB6AAA28. 4. Confirm the date and number of unused incorrectly labeled vials in your inventory. 5. Discard any unused incorrectly labelled vials in your inventory. 6. Please indicate the number of requested replacement vials. Please document the information on the enclosed Return Form and send to [email protected] Transmission of this notice We kindly ask you to inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. We need confirmation of the complete delivery of this lot. By completing the above-mentioned enclosed Return Form by yourself and affected customers.

    Distribution

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

    Quantity

    10752 units