FDA (Devices) recall action 72651
The FDA (Devices) publishes a recall like this one as 59 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 59 pages.
Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ameditech is recalling ProScreen 8 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling ProScreen 6 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling Immutest 11 Pnl Drug Screen Cups because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling DrugSmart 12 Test Cups because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling ProScreen 6 Panel Cup kits because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling Immutest Cup CLIA Waived kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling Immutest 12 Panel Cup kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling 300 kits of the Thermo Fisher 6 Drug Cassette because the tests may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling 120 DrugSmart Dip drug test kits because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling iCup DX 6 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling 10,320 CLIA RDTC 12-Panel Cup kits nationwide because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling 1,909 Immutest 5 Pnl Drug Cup kits due to reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling iCup DX 10 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling ProScreen Cup CLIA drug tests because they may show reduced reactivity for specific benzodiazepine compounds.
Ameditech is recalling 96 kits of ProScProScreen 10 Panel Cups due to reduced reactivity for two benzodiazepine compounds.
Ameditech is recalling ProScreen CLIA Waived Cup kits because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling ProScreen 12 Panel Cups because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
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.
Ameditech is recalling ProScreen 6 Panel Cassette kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling ProScreen 6 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling ProScreen 8 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling DrugSmart 11 Test Cups because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
Ameditech is recalling DrugSmart Cup drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling iCup DX 8 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.
Ameditech is recalling ImmuTest 12 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.