FDA recall Z-0270-2019

Ameditech Inc · Class III · 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.

Reason for recall

Product was released to market without the adulteration strip included in the product.

Distribution

US in the state of California

Key facts

Status
Terminated
Initiation date
2017-09-30
Report date
2018-10-31
Termination date
2019-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2019