Ameditech ProScreen 6 Panel Cassette Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 6 Panel Cassette kits 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 FDA classified this recall as 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 60 kits of the ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU. 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 affected by the reduced reactivity are Clonazepam and Chlordiazepoxide. The affected product was distributed nationwide.
Users of the product should check their inventory for the specific item number and code G150179. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 60
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)
- G150179
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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