medical Class II Updated 2020-10-07

Ameditech Inc recalls Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Descri

Recalled 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)",

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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