FDA Device recall Z-1843-2016
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001)
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001) by Medscience, citing during an FDA inspection it was found that the products are marketed without a cleared 510k.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1843-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-22 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medscience |
| Distribution | US |
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
Reason
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1843-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.