Ameditech Recalls CLIA RDTC 12-Panel Drug Abuse Tests for Reduced Reactivity
Ameditech is recalling 7,482 units of CLIA RDTC 12-Panel Cup drug abuse tests because they have shown reduced reactivity. The products were 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 rating.
Plain-English summary
Ameditech Inc is recalling 7,482 units of CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration) drug abuse tests. These one-step immunoassays are intended for the qualitative detection of multiple drugs and drug metabolites in human urine for professional and point-of-care use. 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 142320, 143666, 143753, 144217, 144414, 144439, 144454, 144510, and 144952.
Healthcare professionals and laboratories using these tests should stop using the affected units and contact Ameditech Inc for further instructions or a return.
The recalled product
- Product
- CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 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 co
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 7,482
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)
- 142320 143666 143753 144217 144414 144439 144454 144510 144952
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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