Ameditech RealityCHECK Tilt Cup Benzodiazepine Test Recall
Ameditech is recalling 80 kits of RealityCHECK Tilt Cup 12 Panel + Adult tests due to reduced reactivity for two benzodiazepine compounds.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a technical performance defect (reduced reactivity) rather than a direct safety hazard like contamination or injury.
Plain-English summary
Ameditech Inc is recalling 80 kits of the RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA. The product was distributed nationwide. The recall is identified by code 153709.
The recall is due to reduced reactivity for up to two of the nineteen benzodiazepine compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide. This issue may impact the accuracy of the drug of abuse tests for these specific substances.
Consumers and healthcare providers should stop using the affected kits. The source text does not provide specific instructions for disposal or return, but users should consult the manufacturer or relevant regulatory authorities for guidance on handling the recalled product.
The recalled product
- Product
- RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 80
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)
- 153709
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 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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