Ameditech Immutest 12 Panel Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling Immutest 12 Panel Cup kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
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 source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ameditech Inc is recalling 200 kits of the Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP. The affected products were distributed nationwide.
The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. Specifically, the tests may show reduced reactivity for Clonazepam and Chlordiazepoxide. The affected lot codes are 143847, 144565, 150313, 152169, and 152338.
This is an FDA Class III recall, which indicates that use of the product is not likely to cause adverse health consequences. Users should check their lot numbers against the list provided and contact Ameditech Inc for further instructions.
The recalled product
- Product
- Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 200
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)
- 143847 144565 150313 152169 152338
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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