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Recall Observatory FDA recall evidence

Device product

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 Tests: Cr, 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)"

Z-3040-2020

August 18, 2020

Class II

Product summary

Firm
Ameditech Inc
Event
Event 86335
Status
Terminated
Classification
Class II
Quantity
136,925 units
Official record key
device-enforcement:Z-3040-2020

Official wording

Reason: 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.

Code information: ALL Lots Within Expiry

Distribution pattern: US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.