Ameditech Inc recalls iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; i

Recalled November 25, 2015 · FDA recall Z-0311-2016 · Ameditech

Hazard

Ameditech is recalling drug abuse tests because they have shown reduced reactivity. · FDA Class II

Units

27,638 units

Sold at

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

Description

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

Product

iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 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. ¿¿¿

Manufacturer(s)

Ameditech Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →