Ameditech Recalls TDDA Drugs of Abuse Cups Due to Performance Failures
Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations or significant injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Ameditech Inc is recalling 26,775 units of TDDA Drugs of Abuse Cups (TDDA-6MBAU-CUP). The affected products are distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. The recall includes all lots within their expiration dates.
The recall was initiated because various immunoassay enzymes in the cups failed product performance tests. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This means the test results may not be accurate.
Healthcare professionals and laboratories using these products should stop using the affected units and contact Ameditech Inc for further instructions. Consumers should not use these products for diagnostic purposes.
The recalled product
- Product
- TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."
- Manufacturer
- Ameditech Inc
- Affected units
- 26,775
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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