Recall Z-0072-2015 ยท DKZ Enzyme Immunoassay, Amphetamine
Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. 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.
| Date | Oct 16, 2014 (initiated Sep 23, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | A customer notification letter dated 9/23/14 was sent to all customers who purchased the ArcPoint Labs Dip Drug Screen Dip Card. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the Verification Form. Customers with questions are instructed to contact Ameditech at (858) 805-8714 or email at amd.complaint@alere.com. |
| Quantity | 80 kits |
| Distribution | Distributed in AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN Ameditech, Inc., Nov 10, 2011 |