Device product
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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.
Z-0301-2016
Product summary
- Firm
- Ameditech Inc
- Event
- Event 72471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-0301-2016
Official wording
Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Code information: 142898 151145 142899
Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia.
Derived failure modes
-
Unknown
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.