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Recall Observatory FDA recall evidence

Device product

ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."

Z-3036-2020

August 18, 2020

Class II

Product summary

Firm
Ameditech Inc
Event
Event 86335
Status
Terminated
Classification
Class II
Quantity
27,375 units
Official record key
device-enforcement:Z-3036-2020

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.