05/11/2022: Lab Alert: Do Not Use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
On May 10, 2022, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). FDA has not authorized, cleared, or approved this test for distribution or use in the United States. FDA is concerned about the risk of false results when using this test because the manufacturer has not provided FDA with adequate data to show that these tests work correctly.
Laboratories and testing sites should be aware of possible false results among consumers who were tested using this product.
The manufacturer (SML Distribution LLC) recalled the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold). FDA has classified this as a Class I recall, the most serious type of recall.
To date, FDA has not received any reports of injuries or death associated with use of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
Please review the safety communication in detail and share this message widely with your networks.
If you have questions about this Safety Communication, email the FDA Division of Industry and Consumer Education (DICE) or call 800-638-2041.
Opt in to receive emails from the CDC Laboratory Outreach Communication System (LOCS).
Online resources:
- Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC Coronavirus (COVID-19) Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)