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U.S. Department of Health and Human Services

Class 2 Device Recall AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multiple Well Test Tra

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  Class 2 Device Recall AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multiple Well Test Tra see related information
Date Initiated by Firm March 22, 2016
Create Date May 31, 2016
Recall Status1 Terminated 3 on October 13, 2017
Recall Number Z-1843-2016
Recall Event ID 73664
Product Classification System, delivery, allergen and vaccine - Product Code LDH
Product 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
Code Information All lots
Recalling Firm/
Manufacturer		 Medscience Inc
16469 Bridlewood Cir
Delray Beach FL 33445-6679
For Additional Information Contact Customer Service
800-393-8817
Manufacturer Reason
for Recall		 During an FDA inspection it was found that the products are marketed without a cleared 510k.
FDA Determined
Cause 2		 No Marketing Application
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.
Quantity in Commerce 11,400 (Item 1000) & 380 (Item 1001)
Distribution Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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