BEUDAMED
    FDA Recall Terminated

    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

    Recall: Z-1842-2015 · Initiated May 19, 2015

    Recall

    Recall Number
    Z-1842-2015
    Event Number
    71291
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    May 19, 2015
    Posted
    June 25, 2015
    Terminated
    March 24, 2017
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

    Reason

    Use of the recalled product may result in false positive reports.

    Action

    Remel, Inc. a part of Thermo Scientific sent a Product Correction Notification dated May 19, 2015, to all affected customers. The notification states the problem with the device and that the recalling firm's Technical Services department will be contacting the customer to schedule a field service of the device to correct the issue. Customers were instructed to notify any personnel who need to be notified of the potential for a false positive resulting from rare inconsistent barometric pressure readings. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice of the affected product. If product was further distributed customers were instructed to contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-642-7029. For questions regarding this recall call 770-409-0713.

    Distribution

    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.

    Quantity

    21 devices