Z-0071-2015Class II

ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a...

Name: Z-0071-2015 ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a...
Creator: Ameditech Inc
Published: 2014-09-23
License: https://open.fda.gov/license/

Ameditech, Inc. / initiated 2014-09-23 / Terminated / root cause: labeling and UDI

FDA source

Ameditech Inc began a 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 qualitative detection of... on 2014-09-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0071-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-23
Posted: 2014-10-16
Terminated: 2015-02-27
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.
Product code: DKZ Enzyme Immunoassay, Amphetamine
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.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 400 kits
Distribution: Distributed in AL.
Product codes and lots: Lot No. 141012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0072-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0073-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

Product code DKZ

K113046Class IIAmeditech Immutest Milti-Drug ScreenAmeditech, Inc. / cleared 2011-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)