Ameditech Inc recalls iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131

Recall date

November 16, 2015

Source

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

Recall number

Z-0503-2016

FDA classification

Class III

Brand / firm

Ameditech Inc

Sold / distributed

Nationwide Distribution.

Why it was recalled

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

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

What was recalled

iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131