Z-0270-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- September 30, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 kit boxes (1000 units)
Product 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 for Recall
Product was released to market without the adulteration strip included in the product.
Distribution Pattern
US in the state of California
Code Information
Part Number: DS84S625, Lot Number: 174886 (US distribution only)