RecallRadar

FDA Device recall Z-0526-2016

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

On 2015-12-30 the FDA classified a Class III recall of ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU by Ameditech, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0526-2016
ClassificationClass III
Statusterminated
Initiated2015-11-16
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanyAmeditech
DistributionUS

Product

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

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.

Identifiers

code_infoG140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0526-2016%22

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