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Terminated

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

FDA Recall Z-1843-2016 · Posted None

Recalling FirmMedscience Inc
Recall StatusTerminated
Product CodeLDH
Date Initiated2016-03-22
Date Terminated2017-10-13
Product Quantity11,400 (Item 1000) & 380 (Item 1001)

Reason for Recall

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

Firm 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 [email protected].

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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