Ameditech Recalls 1 Step 12 Panel Cup Drug Tests
Ameditech is recalling 787 kits of 1 Step 12 Panel Cup drug tests due to 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. The hazard is reduced reactivity, which is a functional defect rather than a direct physical or biological hazard like a pathogen or structural failure. No injuries or illnesses are reported in the source text.
Plain-English summary
Ameditech Inc is recalling 787 kits of the 1 Step 12 Panel Cup, Item No. NBCA-12M-W. These are one-step immunoassay tests used for the qualitative detection of multiple drugs and drug metabolites in human urine, including Benzodiazepine (BZO). The tests are intended for professional and point-of-care use.
The recall was initiated because the drug abuse tests have shown reduced reactivity. The affected products were distributed nationwide in the United States and internationally to Australia. The source text does not specify any reported illnesses, injuries, or specific lot numbers beyond the provided code information.
Consumers and healthcare professionals should stop using the recalled products and contact Ameditech Inc for further instructions or a refund.
The recalled product
- Product
- 1 Step 12 Panel Cup, Item No. NBCA-12M-W 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, including
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 787
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)
- 144408 150675
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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