Ameditech Inc recalls THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for…

Recall date

October 20, 2015

Source

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

Recall number

Z-0317-2016

FDA classification

Class II

Brand / firm

Ameditech Inc

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia.

Why it was recalled

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

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

What was recalled

THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿