Medical device recalls

Ameditech Inc recalls DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

Recall date
November 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0495-2016
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

DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

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