Ameditech Drug Screening Components Recalled for Performance Failures
Ameditech Inc is recalling specific drug screening components because they failed to consistently detect compounds at labeled levels.
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 hazard involves performance failures leading to inconsistent detection, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Ameditech Inc is recalling specific drug screening components, including uncut sheets and cups, due to performance failures. The affected products include various part numbers and lot numbers, such as 100163, 100195, and 160130, among others. The recall covers 3,600 units distributed nationwide in the US and in Australia, France, Germany, New Zealand, Singapore, and Spain.
The recall was initiated because various immunoassay enzymes in these products failed to meet performance standards. Specifically, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This inconsistency may affect the accuracy of drug screening results.
Users of these products should stop using them and contact Ameditech Inc for further instructions. The recall includes all lots within their expiry dates.
The recalled product
- Product
- Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Shee
- Manufacturer
- Ameditech Inc
- Affected units
- 3,600
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)
- ALL Lots Within Expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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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