Medical device recalls Moderate risk

Ameditech Inc recalls Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Scr…

Recall date
August 18, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3041-2020
FDA classification
Class II
Brand / firm
Ameditech Inc
Sold / distributed
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Why it was recalled

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Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "

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