Ameditech Recalls 11 Panel Drug Abuse Tests Due to Reduced Reactivity
Ameditech is recalling 11 Panel Drug Abuse Tests because they have shown reduced reactivity. The affected products are distributed in the US and Australia.
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, and the source text does not report any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Ameditech Inc is recalling 11 Panel Cup (OPI2000) w/Adult (Item No. 71125AA2K) and 11 Panel Cup (OPI300) w/Adult (Item No. 71125AA) drug abuse tests. These products are one-step immunoassays intended for the qualitative detection of multiple drugs and drug metabolites in human urine for professional and point-of-care use.
The recall was initiated because the tests have shown reduced reactivity. The affected units were distributed nationwide in the United States and internationally to Australia.
Consumers and healthcare professionals should stop using the affected products and contact Ameditech Inc for further instructions.
The recalled product
- Product
- 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA 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 o
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 100
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)
- 150503 144376
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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