Medscience Inc: Medical Device Recall in 2016 - (Recall #: Z-1843-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 22, 2016

Date Posted: June 8, 2016

Recall Number: Z-1843-2016

Event ID: 73664

Reason for Recall:

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

Status: Terminated

Product Quantity: 11,400 (Item 1000) & 380 (Item 1001)

Code Information:

All lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated