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Ameditech Inc recalls Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500;
Recalled October 7, 2020 · FDA recall Z-3039-2020 · 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
13,700 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
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150)+(OPI300/MET500)+ (AMP500/BZO300)+(BAR300/MTD300)+ (BOPG10/TCA1000)+(MDMA500/OXY100)+ (PCP25/PPX300) w/ Cr, Ni, pH, Bl, S.G."
Manufacturer(s)
Ameditech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →