FDA Enforcement
Class II
Terminated
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Recall: Z-0300-2016
·
Reported November 25, 2015
Enforcement
- Recall Number
- Z-0300-2016
- Event ID
- 72471
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ameditech Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 25, 2015
- Initiation Date
- October 20, 2015
- Classification Date
- November 18, 2015
- Termination Date
- November 9, 2016
- Address
- 9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States
Description
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
Reason
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Code Info
150503 144376
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Quantity
100 units