Today, the
FDA is warning people to not use the Skippack Medical Lab SARS-CoV-2 Antigen
Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved
by the FDA for distribution or use in the United States. The FDA is concerned
about the risk of false results when using this test because SML Distribution
LLC has not provided the FDA with adequate data to show the tests work
correctly.
SML
Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid
Tests (Colloidal Gold), and the FDA has identified this issue as a Class I
recall, the most serious type of recall.
The FDA has not received reports of injuries or death associated with use of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
This information has been broadcast to: Community Health Centers (FQHCs); Emergency Medical Services / First Responders; Long-term Care; Health Care Facilities / Other; Health Care Organizations; Health Care Providers; Hospital Staff Directory; Hospital CEOs; Hospital Emerg Preparedness Coords; Hospital ER Medical Directors; Hospital Infection Control Practitioners; Hospital Medical Directors; Hospital Nursing Directors; Hospital Security Directors; ICU Administrator; Lab Director; Hospitals / Acute Care; Hospitals / Other; Hospitals / Veterans; Labs / Non-Sentinel; Labs / Sentinel; Occupational Health Organizations; Pharmaceutical Suppliers; Local Boards of Health; NJDOH Staff; NJLINCS and Local Contacts; NJLINCS Community; Public Health Associations; Public Health Council; Public Health Sector