Ameditech Recalls ProScreen Drug Panel Tests Due to Reduced Reactivity
Ameditech is recalling ProScreen drug panel tests because they have shown reduced reactivity. The recall covers 31,530 units 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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Ameditech Inc is recalling various ProScreen drug panel tests, including cassette tests, cups, and dip cards, because they have shown reduced reactivity. The affected 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 involves 31,530 units of these tests. The products were distributed nationwide in the United States and internationally to Australia. Specific lot codes are listed in the official recall documentation.
Consumers and healthcare professionals should stop using the affected ProScreen drug panel tests and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PS
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 31,530
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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