Device product
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. 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.
Z-0073-2015
Product summary
- Firm
- Ameditech Inc
- Event
- Event 69333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320 kits
- Official record key
device-enforcement:Z-0073-2015
Official wording
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.
Code information: Lot No. 141001
Distribution pattern: Distributed in AL.
Derived failure modes
-
Unknown
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.