Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error
Ameditech is recalling 320 kits of the ArcPoint Labs 10 Panel Dip Screen (OXY) because the positive interpretation illustration on the cap labels and package insert was incorrect.
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 specific defect is a labeling error regarding interpretation illustrations. This aligns with the rubric for 'Minor labeling errors' or 'voluntary precautionary recalls' where no direct physical injury or high-risk pathogen is involved.
Plain-English summary
Ameditech Inc is recalling 320 kits of the ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The product is a one-step immunoassay used for the qualitative detection of multiple drugs and drug metabolites in human urine.
The recall was initiated because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert. This labeling error could potentially lead to misinterpretation of test results.
The affected product, identified by Lot No. 141001, was distributed in Alabama. Consumers and healthcare providers who have this product should stop using it and contact Ameditech Inc for further instructions.
The recalled product
- Product
- ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 320
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)
- Lot No. 141001
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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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