FDA Enforcement
Class III
Terminated
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
Recall: Z-0488-2016
·
Reported December 30, 2015
Enforcement
- Recall Number
- Z-0488-2016
- Event ID
- 72651
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ameditech Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2015
- Initiation Date
- November 16, 2015
- Classification Date
- December 24, 2015
- Termination Date
- November 9, 2016
- Address
- 9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States
Description
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
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 Info
151688 152423 153307 153912 153921 153961 153962 154104 154112 154236 154264
Distribution
Nationwide Distribution.
Quantity
858 kits