BEUDAMED
    FDA Recall Terminated

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    Recall: Z-1267-2014 · Initiated February 11, 2014

    Recall

    Recall Number
    Z-1267-2014
    Event Number
    67599
    Firm
    AMS Diagnostics, LLC
    FEI Number
    3009128555
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 11, 2014
    Posted
    March 21, 2014
    Terminated
    September 29, 2016
    Address
    1790 N Commerce Pkwy, Weston, FL, 33326-3204

    Description

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    Reason

    Marketing the devices outside 510(k) requirements

    Action

    AMS Diagnostics sent a Recall Notification letter dated February 11, 2014 to all affected customers. The letter instructed the customers to: 1) Review their inventory for the lots listed and if they currently have them, to discard and notify the firm for a replacement. 2) If they don't have the lots listed, please check the box, sign, date and return the letter via fax at (954) 217-0046 or email to [email protected]. Customers with questions were instructed to call 954-217-0040 ext. 302. For questions regarding this recall call 954-217-0040.

    Distribution

    Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.

    Quantity

    167 kits