Device product
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU 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-0317-2016
Product summary
- Firm
- Ameditech Inc
- Event
- Event 72471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220 units
- Official record key
device-enforcement:Z-0317-2016
Official wording
Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Code information: G150094 G150136
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.