Device product
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P 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-0312-2016
Product summary
- Firm
- Ameditech Inc
- Event
- Event 72471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1172 units
- Official record key
device-enforcement:Z-0312-2016
Official wording
Reason: Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Code information: 144380 144564 150505 150908 151538 142098 144103 150313 150909 141645 144563 150483 151337 142076 142966 144263 151540
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.