Ameditech 10-Panel Pipette Drug Screen Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling 10-Panel Pipette Drug Screen 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 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 240 kits of the 10-Panel Pipette Drug Screen, Item No. PSP-10M. The recall covers products with codes 153135 and 154119 that were distributed nationwide.
The recall was initiated because the drug tests have shown 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, indicating that use of the product is not likely to cause adverse health consequences. Users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 10-Panel Pipette Drug Screen, Item No. PSP-10M
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 240
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)
- 153135 154119
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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