FDA Medical Device Recalls (openFDA)
Medscience Inc: 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
- Recall number
- Z-1843-2016
- Recalling firm
- Medscience Inc
- 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
- Status
- Terminated
- Initiated
- 2016-03-22
- Posted
- not on file
- Terminated
- 2017-10-13
- Reason
- During an FDA inspection it was found that the products are marketed without a cleared 510k.
- Root cause
- No Marketing Application
- 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 recall@medscienceinc.com.
- Quantity
- 11,400 (Item 1000) & 380 (Item 1001)
- Distribution
- Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LDH
- Firm FEI
- 3010131789
- Firm city
- Delray Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28