The Recall Desk
ModerateFDA (Devices)·Z-0488-2016·Announced 2015-12-30

Ameditech 12-Panel Dip Drug Screen Recalled for Reduced Benzodiazepine Reactivity

Ameditech is recalling 12-Panel Dip Drug Screen kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard or contamination.

Plain-English summary

Ameditech Inc is recalling 858 kits of the 12-Panel Dip Drug Screen with adulterant. The affected products include Item Nos. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, and IMCA-10M5. These products were distributed nationwide.

The recall was initiated because the 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 reduced reactivity may impact the accuracy of the drug screening results for these specific substances.

Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for further instructions or a replacement.

The recalled product

Product
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
Manufacturer
Ameditech Inc
Affected units
858

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.

See all 59 products in this recall →