Medscience product recalled over undeclared allergens

Recall date

March 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medscience Inc recalls AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Con…

Recall number

Z-1843-2016

FDA classification

Class II

Brand / firm

Medscience Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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