The Recall Desk

FDA (Devices) recall action 69333

Ameditech Inc recalled 3 products on 2014-10-22

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-10-22
Critical
0
Units
800

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2014-10-22

    Ameditech Recalls ArcPoint Labs 5 Panel Dip Drug Screen Due to Labeling Error

    Ameditech is recalling 400 kits of the ArcPoint Labs 5 Panel Dip Drug Screen because the positive interpretation illustration on the labels and package insert was incorrect.

    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.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-10-22

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error

    Ameditech is recalling 80 kits of ArcPoint Labs 10 Panel Dip Screen because the positive interpretation illustration on the cap labels and package insert was incorrect.

    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.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-10-22

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error

    Ameditech is recalling 320 kits of the ArcPoint Labs 10 Panel Dip Screen (OXY) because the positive interpretation illustration on the cap labels and package insert was incorrect.

    Product
    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. 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.
    Category
    Distribution
    1 state