Ameditech Inc recalls ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC

Recalled October 7, 2020 · FDA recall Z-3045-2020 · Ameditech

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. · FDA Class II

Units

189,175 units

Sold at

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

Description

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.

Product

ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR - NI - PH - BL - S.G.", DT14/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300", HT15/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/PCP25/ THC50/OPI2000", HT15A/ ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/PCP25/ THC50/OPI2000 Adulteration Screen for CR - NI - PH - BL - S.G.", PT15/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/OPI300/THC50" DT13A/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr, Ni, pH, BI, S.G.", DT14A "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300 w/ Cr, Ni, pH, Bl, S.G. Finished Devices", DT12A/"ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; PCP25/PPX300 w/ Cr, Ni, pH, BI, S.G.", PT12A/ "ToxCup¿ Drug Screen Cup COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR - NI - PH - BL - S.G.", PT11A/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR - NI - PH - BL - S.G.", HT30/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET1000/PCP25/THC50/ OPI2000"

Manufacturer(s)

Ameditech Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →