ArcPoint Labs 5 Panel Dip Drug Screen — Class II medical device recall Z-0071-2015
Terminated recall by Ameditech Inc, reported 2014-10-22. Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustra
| Recall number | Z-0071-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameditech Inc, San Diego, CA, United States |
| Recall initiated | 2014-09-23 |
| Classified | 2014-10-16 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2015-02-27 |
| Quantity | 400 kits |
| Reason classes | labeling |
| Lot numbers | 141012 |
| Model numbers | APD-5M |
Product
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
Reason for recall
Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.
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-0071-2015. 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.