FDA recall Z-0692-2020

Ameditech Inc · Class III · device

Product

QuickTox 5 Panel Drug Screen DipCard

Reason for recall

Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)

Distribution

US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None

Key facts

Status
Terminated
Initiation date
2019-02-15
Report date
2019-12-25
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0692-2020