AllergiEnd ST-9 Multiple Skin Test Applicator — Class II medical device recall Z-1843-2016
Terminated recall by Medscience Inc, reported 2016-06-08, distributed nationwide. During an FDA inspection it was found that the products are marketed without a cleared 510k.
| Recall number | Z-1843-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medscience Inc, Delray Beach, FL, United States |
| Recall initiated | 2016-03-22 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-10-13 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| Model numbers | 1000 |
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 for recall
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1843-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.