Ameditech Recalls Immutest Drug Screen Cups Due to Reduced Reactivity
Ameditech is recalling specific Immutest drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and in 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 hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ameditech is recalling several models of Immutest drug screen cups, including 5, 7, 10, 11, and 12-panel configurations. These products are one-step immunoassays intended for the qualitative detection of multiple drugs and drug metabolites in human urine. The recall is being conducted because the tests have shown reduced reactivity.
The affected units were distributed nationwide in the United States and internationally to Australia. A total of 1,172 units are involved in this recall. The specific item numbers and lot codes are listed in the official recall documentation.
Consumers and healthcare professionals should stop using the affected Immutest drug screen cups and contact Ameditech for further instructions or a replacement.
The recalled product
- Product
- Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMC
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 1,172
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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