Ameditech Recalls 10-Panel Pipette Drug Screen Due to Reduced Reactivity
Ameditech is recalling 10-Panel Pipette Drug Screen tests because they have shown reduced reactivity. The recall affects 200 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. The hazard involves reduced reactivity in a diagnostic test, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Ameditech Inc is recalling 200 units of the 10-Panel Pipette Drug Screen, Item No. PSP-10M. These are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine, intended 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.
Consumers and healthcare professionals should stop using the affected drug screens and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- 10-Panel Pipette Drug Screen, Item No. PSP-10M 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 consist of a combination of drug strips, incl
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 200
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)
- 133930 143597
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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