medical Class II Updated 2020-10-07

Ameditech Inc recalls ToxCup Drug Screen Cup (AMT Item Number/ AMT Description):

Recalled 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"

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ALL Lots Within Expiry
View official government recall

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