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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Ameditech Inc
- Hazard
- 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.
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