The Recall Desk
ModerateFDA (Devices)·Z-0316-2016·Announced 2015-11-25

Ameditech Recalls 6 Panel Drug Detection Cups Due to Reduced Reactivity

Ameditech is recalling 2,240 units of 6 Panel Cup Body and Lid drug tests because they have shown reduced reactivity.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Ameditech is recalling 2,240 units of the Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP. These products are one-step immunoassays intended for the qualitative detection of multiple drugs and drug metabolites in human urine, including Benzodiazepine (BZO). The recall is being conducted because the tests have shown reduced reactivity.

The affected products were distributed nationwide in the United States and internationally to Australia. The specific lot codes associated with this recall are G140422-C, G150059-C, G150063-C, and G150132-C.

Users of these products should stop using them and contact Ameditech for further instructions.

The recalled product

Product
The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP 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
Manufacturer
Ameditech Inc
Affected units
2,240

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 (1)

  • G140422-C G150059-C G150063-C G150132-C

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Ameditech Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →