FDA Medical Device Recalls (openFDA)
Ameditech Inc: 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.
- Recall number
- Z-0071-2015
- Recalling firm
- Ameditech Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-09-23
- Posted
- 2014-10-16
- Terminated
- 2015-02-27
- 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
- 400 kits
- Distribution
- Distributed in AL.
- Lot, serial or model codes
- Lot No. 141012
- 510(k) numbers
- ["K113046"]
- PMA numbers
- not on file
- Product code
- DKZ
- Firm FEI
- 3003789989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28