FDA recall Z-0929-2023

Product

Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

Reason for recall

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Distribution

U.S. Nationwide distribution in the states of CA, and TX.

Key facts

Status

Ongoing

Initiation date

2022-11-28

Report date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fresno, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2023