FDA recall Z-0947-2022

Matrix Medical Network · Class II · device

Product

Matrix Clinical Solution At-Home COVID-19 Test

Reason for recall

Due to COVID-19 Test not being authorized for home sample collection.

Distribution

U.S.: AL, AZ, CA, CO, CT, DC, DE, FL, GA, LA, MA, MD, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, and WV. O.U.S.: N/A

Key facts

Status
Ongoing
Initiation date
2022-01-24
Report date
2022-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2022