Ameditech Immutest 5 Pnl Drug Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling 1,909 Immutest 5 Pnl Drug Cup kits due to reduced reactivity for two specific benzodiazepine compounds.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ameditech Inc is recalling 1,909 units of the Immutest 5 Pnl Drug Cup w/ Adult -waived (Item No. IMCA-5AB-W). 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.
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. The source text does not specify a date range for distribution or report any illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for further instructions or a replacement. The recall number is Z-0509-2016.
The recalled product
- Product
- Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
- Manufacturer
- Ameditech Inc
- Hazard
- Affected units
- 1,909
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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