Ameditech ProScreen 10 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 10 Panel Dip Cards because they may show 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 by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or minor performance issues.
Plain-English summary
Ameditech Inc is recalling 1,989 kits of ProScreen 10 Panel Dip Cards with Adult. The affected products include various item numbers such as PSDA-10MO, PSDA-10MMO300, and PSCupA-10MO. 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 for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. This issue may affect the accuracy of the drug of abuse tests for these specific substances. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for further instructions or a replacement. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
- Manufacturer
- Ameditech Inc
- Affected units
- 1,989
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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