ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step imm
FDA device recall Z-0073-2015 · posted 2014-10-16 · Terminated
Recall details
- Recalling firm
- Ameditech Inc
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DKZ
- Quantity affected
- 320 kits
- Distribution
- Distributed in AL.
- Date initiated
- 2014-09-23
- Date posted
- 2014-10-16
- Date terminated
- 2015-02-27
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMEDITECH IMMUTEST MILTI-DRUG SCREEN (K113046) | Ameditech, Inc. | 2011-11-10 |