Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Reduced Reactivity
Ameditech is recalling ArcPoint Labs 10 Panel Dip Screen (OXY) drug tests because they have shown reduced reactivity.
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 hazard is reduced reactivity (potential false negatives) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ameditech is recalling the ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO, because the drug abuse tests have shown reduced reactivity. These tests are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine, including Benzodiazepine (BZO). They are intended for professional and point-of-care use.
The recall involves 320 units of the product. The affected units were distributed nationwide in the United States and internationally to Australia. The specific code for the recalled units is 141001.
Consumers and healthcare professionals should stop using the recalled drug tests and contact Ameditech for further instructions or a replacement.
The recalled product
- Product
- ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO 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…
- 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)
- 141001
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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