Device product
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.
Z-0270-2019
Product summary
- Firm
- Ameditech Inc
- Event
- Event 80861
- Status
- Terminated
- Classification
- Class III
- Quantity
- 40 kit boxes (1000 units)
- Official record key
device-enforcement:Z-0270-2019
Official wording
Reason: Product was released to market without the adulteration strip included in the product.
Code information: Part Number: DS84S625, Lot Number: 174886 (US distribution only)
Distribution pattern: US in the state of California
Derived failure modes
-
Unknown
Product was released to market without the adulteration strip included in the product.