Ameditech Noble 1 Step+ Cup Recalled for Inconsistent Performance
Ameditech is recalling Noble 1 Step+ 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, and the source text describes a performance failure without reporting any specific injuries, illnesses, or deaths, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Ameditech Inc is recalling approximately 13,700 units of the Noble 1 Step+ Cup. These are finished devices used for drug testing that include specific calibrator and secondary compound detection capabilities.
The recall was initiated because various immunoassay enzymes in the products failed to meet performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The affected units were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. All lots within the expiry date are included in this recall.
The recalled product
- Product
- Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup"…
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Drug Testing
- Hazard
- Affected units
- 13,700
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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