FDA Enforcement
Class III
Terminated
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.
Recall: Z-0270-2019
·
Reported October 31, 2018
Enforcement
- Recall Number
- Z-0270-2019
- Event ID
- 80861
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ameditech Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 31, 2018
- Initiation Date
- September 30, 2017
- Classification Date
- October 25, 2018
- Termination Date
- August 6, 2019
- Address
- 9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States
Description
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.
Reason
Product was released to market without the adulteration strip included in the product.
Code Info
Part Number: DS84S625, Lot Number: 174886 (US distribution only)
Distribution
US in the state of California
Quantity
40 kit boxes (1000 units)