FDAFDA · Food and drugs·Recall number Z-3036-2020
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."
Published October 7, 2020 · Recall initiated: August 18, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ameditech Inc
- Distributor
- US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
- Lot
- ALL Lots Within Expiry
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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