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Ameditech Inc recalls Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Pane
Recalled October 7, 2020 · FDA recall Z-3035-2020 · 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
31,800 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
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
Manufacturer(s)
Ameditech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →