Ameditech Inc recalls Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detec…

Recall date

September 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0270-2019

FDA classification

Class III

Brand / firm

Ameditech Inc

Sold / distributed

US in the state of California

Why it was recalled

Product was released to market without the adulteration strip included in the product.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.