PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: December 30, 2015 Initiated: November 16, 2015 #Z-0491-2016

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Ameditech Inc
Units Affected
10,320 kits
Distribution
Nationwide Distribution.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5. Recalled by Ameditech Inc. Units affected: 10,320 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2015. Severity: Low. Recall number: Z-0491-2016.