FDA recall Z-1594-2023

Product

Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

Reason for recall

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2023-03-31

Report date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suwon, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1594-2023