Home / Recalls / Medical Devices
Ameditech Inc recalls Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Dr
Recalled October 7, 2020 · FDA recall Z-3034-2020 · 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
108,000 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
Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect¿ II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MTD300", MF21/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: TCA1000, MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300, MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300", QF12/ "Fastect¿ II Drug Screen Dipstick Test 4 Drug Detection: THC50+COC300+OPI300+MET500", MF10/ "Fastect¿ II Drug Screen Dipstick Test THC50", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF16 /"Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MET500", MF23 /"Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF14/ "Fastect¿ II Drug Screen Dipstick Test AMP1000", MF11/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: COC300", MF23 / Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100"
Manufacturer(s)
Ameditech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →