Events

Recall of Device Recall AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multiple Well Test Tra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medscience Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73664
  • Event Risk Class
    Class 2
  • Event Number
    Z-1843-2016
  • Event Initiated Date
    2016-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144685
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, delivery, allergen and vaccine - Product Code LDH
  • 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 recall@medscienceinc.com.

Device

Device Recall AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multip...
  • Model / Serial
    All lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
  • Product 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
  • Manufacturer
    Medscience Inc

Manufacturer

Medscience Inc
  • Manufacturer Address
    Medscience Inc, 16469 Bridlewood Cir, Delray Beach FL 33445-6679
  • Source
    USFDA