Ameditech 11 Panel Card Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling 50 kits of the 11 Panel Card (OPI 300) w/Adult because the tests showed 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 the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Ameditech Inc is recalling 50 kits of the 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA. The product was distributed nationwide.
The recall was initiated because the drugs of abuse tests showed 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.
This recall is classified as Class III by the FDA. Users should stop using the affected product and contact the manufacturer for instructions.
The recalled product
- Product
- 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 50
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)
- 144376
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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