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

This recall has been terminated (originally issued March 22, 2016).

Company

Medscience Inc

Recall Initiated

March 22, 2016

Terminated

October 13, 2017

Recall Number

Z-1843-2016

Quantity

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

Firm Location

Delray Beach, FL

Official Source

View on FDA website ↗

Reason for Recall

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

Distribution

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

Lot / Code Info

All lots

Root Cause

No Marketing Application

Action Taken

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.