Reported Oct 7, 2020 · Terminated

iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug…

Ameditech Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ameditech Inc · 9940 Mesa Rim Rd · San Diego, CA · 92121-2910

Is this the product you have?

  • iCup Dx14 Drug Screen
  • Cup(AMT Item Number/ AMT Description)X11-I-DXA-2147-011/ "iCup"
  • Dx 14 Drug Screen Cup 14 Drug Detection(THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5
  • Adulteration TestsCr, Ni, pH, Bl, S.G.", X11-I-DX-1147-022 /"iCup"
  • Dx 14 Drug Screen Cup 14 Drug Detection(THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300)"
Lot codes and dates
  • ALL Lots Within Expiry
Amount recalled
136,925 units

This recall covers 23 products

The agency filed one notice per product. You are reading one of them; the other 22 are below.

10 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 30, 2024 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.