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Medscience Inc recalls AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Cont
Recalled June 8, 2016 · FDA recall Z-1843-2016 · Medscience
Hazard
During an FDA inspection it was found that the products are marketed without a cleared 510k. · FDA Class II
Units
11,400 (Item 1000) & 380 (Item 1001)
Sold at
Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
Description
During an FDA inspection it was found that the products are marketed without a cleared 510k.
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
Manufacturer(s)
Medscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →