Ameditech iCup DX 11 Panel Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling iCup DX 11 Panel tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Ameditech Inc is recalling 26 units of the iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131. The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide.
The affected products were distributed nationwide. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected test kits and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
- Manufacturer
- Ameditech Inc
- Affected units
- 26
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)
- 152459 152823
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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