FDA Device recall Z-0071-2015
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 qualit…
- FDA Device
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of 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 qualit… by Ameditech, citing 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 graph….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0071-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-23 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ameditech |
| Distribution | AL |
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
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.
Identifiers
| code_info | Lot No. 141012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0071-2015%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.