Z-1843-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2016
- Initiation Date
- March 22, 2016
- Termination Date
- October 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,400 (Item 1000) & 380 (Item 1001)
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
Reason for Recall
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Distribution Pattern
Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
Code Information
All lots