The Recall Desk
LowFDA (Devices)·Z-0270-2019·Announced 2018-10-31

Ameditech Recalls Accutest Drug Test Cups Missing Adulteration Strip

Ameditech Inc is recalling Accutest Drug Test Cup 5+3 units because they were released without the required adulteration strip.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a missing component that affects test functionality rather than a direct physical hazard like injury or illness.

Plain-English summary

Ameditech Inc is voluntarily recalling 40 boxes (1,000 units) of Accutest Drug Test Cup 5+3. The product is an in vitro diagnostic test used for the rapid detection of multiple drugs in human urine. The recall is limited to units with Part Number DS84S625 and Lot Number 174886, which were distributed in California.

The recall was initiated because the product was released to market without the adulteration strip included in the package. This component is necessary for the intended use of the test.

Consumers who have this specific lot of the product should stop using it and contact Ameditech Inc for instructions on how to return or dispose of the product.

The recalled product

Product
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the pres
Manufacturer
Ameditech Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number: DS84S625
  • Lot Number: 174886 (US distribution only)

Distribution

Distributed in 1 state: