Device product
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C 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-0308-2016
Product summary
- Firm
- Ameditech Inc
- Event
- Event 72471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1220 units
- Official record key
device-enforcement:Z-0308-2016
Official wording
Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Code information: 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196
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.