Ameditech Drugs of Abuse Tests Recalled for Reduced Benzodiazepine Reactivity
Ameditech is recalling 3,603 kits of 6 Panel Cup Body and Lid w/Adult (AU) because they show 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 by definition indicates the product is not likely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard.
Plain-English summary
Ameditech Inc is recalling 3,603 kits of the 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP. The products were distributed nationwide. The recall affects specific lot codes: G140255-C, G140422-C, G150063-C, G150184-C, G150211-C, G150226-C, G150240-C, and G150286-C.
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 with potentially reduced reactivity are Clonazepam and Chlordiazepoxide. This issue may affect the accuracy of test results for these specific substances.
Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for instructions on returning the products or obtaining a replacement.
The recalled product
- Product
- 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
- Manufacturer
- Ameditech Inc
- Affected units
- 3,603
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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