Skip to content
Recall Observatory FDA recall evidence

Device product

ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

Z-0526-2016

November 16, 2015

Class III

Product summary

Firm
Ameditech Inc
Event
Event 72651
Status
Terminated
Classification
Class III
Quantity
7,805 kits
Official record key
device-enforcement:Z-0526-2016

Official wording

Reason: 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.

Code information: G140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.