BEUDAMED
    FDA Recall Terminated

    AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine

    Recall: Z-1843-2016 · Initiated March 22, 2016

    Recall

    Recall Number
    Z-1843-2016
    Event Number
    73664
    Firm
    Medscience Inc
    FEI Number
    3010131789
    Product Code
    LDH
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 22, 2016
    Terminated
    October 13, 2017
    Address
    16469 Bridlewood Cir, Delray Beach, FL, 33445-6679

    Description

    AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine

    Reason

    During an FDA inspection it was found that the products are marketed without a cleared 510k.

    Action

    MedScience sent an Urgent Recall letter dated March 28, 2016, to their customers to inform them of the product recall. The letter instructed customers to discontinue and refrain from further use of recalled products and to contact MedScience to arrange the return of products still in possession by the consignee. MedScience set up a phone line and email address for customers to ask questions and obtain further direction: (800) 393-8817 and [email protected].

    Distribution

    Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.

    Quantity

    11,400 (Item 1000) & 380 (Item 1001)