Ameditech Inc: Medical Device Recall in 2015 - (Recall #: Z-0311-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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. ¿¿¿

Product Classification:

Class II

Date Initiated: October 20, 2015

Date Posted: November 25, 2015

Recall Number: Z-0311-2016

Event ID: 72471

Reason for Recall:

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

Status: Terminated

Product Quantity: 27,638 units

Code Information:

141210 141425 141561 141870 141994 142126 143608 144152 144218 145067 150105 150167 151215 150976 141844 141929 142258 142314 143606 144511 145058 145059 150549 150867 150919 150920 151179 151190 151255 151338 151476 144377 150101 150285 150420 151161 151399 151696 144209 144463 150018 150107 150690 150883 141492 141519 141552 141726

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated