FDA recall Z-1044-2022

Woodside Acquisitions Inc. · Class I · device

Product

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

Reason for recall

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Distribution

US distributions to states of: AL and GA.

Key facts

Status
Ongoing
Initiation date
2022-04-09
Report date
2022-05-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
tyrone, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2022