Recall Z-0072-2015— Ameditech Inc
Class II · Terminated
Class II FDA medical device recall by Ameditech Inc, initiated 2014-09-23, terminated 2015-02-27. It names one FDA 510(k) clearance: K113046. Product: 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.. 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..
- Recalling firm
- Ameditech Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-23
- Terminated
- 2015-02-27
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.