RecallRadar

FDA Device recall Z-0491-2016

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

On 2015-12-30 the FDA classified a Class III recall of CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 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-0491-2016
ClassificationClass III
Statusterminated
Initiated2015-11-16
Published2015-12-30
Last updated2026-09-13 11:53 UTC
CompanyAmeditech
DistributionUS

Product

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

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_info142709 142840 143008 143571 143665 144217 152234 152379

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-0491-2016%22

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