RecallRadar

FDA Device recall Z-0494-2016

DrugSmart 11 Test Cup, Item No. 61127D

On 2015-12-30 the FDA classified a Class III recall of DrugSmart 11 Test Cup, Item No. 61127D 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-0494-2016
ClassificationClass III
Statusterminated
Initiated2015-11-16
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanyAmeditech
DistributionUS

Product

DrugSmart 11 Test Cup, Item No. 61127D

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_info144196 144375 150096 151980 152737

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-0494-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.