Dive Brief:

• The Food and Drug Administration labeled another COVID-19 rapid antigen test as a Class I event, assigning the highest risk category to SML Distribution’s withdrawal of 209,450 unauthorized products.
• SML began contacting its customers by phone in March and went on to email a recall notice later that month. The letter explains that SML is recalling its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) because it is not authorized for use in the U.S. As of March 20, the date on the recall letter, the company said it had received no reports of false positives or negatives.
• The FDA’s categorization of the recall as a Class I event reflects the potential for false results to cause COVID-19 infections to go undetected, putting the individual and those around them at risk, and for healthy people to quarantine unnecessarily because of a false positive result.

Dive Insight:

The winter surge in demand for rapid antigen tests in the U.S. has been followed by a wave of regulatory actions by the FDA, which has issued a series of Class I recall notices in relation to the supply of unauthorized COVID-19 tests. The SML notice comes one week after FDA shared details of a recall of 311,100 Celltrion tests that may have been sent to unauthorized users that lack CLIA certification.

Many of the recent recalls involve companies that have received emergency use authorization for a test but have run afoul of the FDA because other versions, such as those intended for use in the European Union, have entered the U.S. market. 

The SML case is somewhat different. SML is not listed by the FDA among the companies with EUAs for rapid antigen tests. Skippack Medical Lab, the company from which SML derives its name, also is absent from the list. 

Skippack Medical Lab provides a range of COVID-19 and non-COVID-19 testing services and has been in business for more than 40 years, while SML is a newer operation. Google first indexed its website in October 2021. The website, which said SML offered US-manufactured SARS CoV-2 rapid antigen tests, featured an “under construction” holding page as of March 2022.

An instruction for use document for the SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) was released in September 2021. The document describes the product as a laboratory-developed test that achieved 98.72% sensitivity and 97.32% specificity in a study of 190 samples collected in China.

The text carries a CE mark and Lotus NL B.V., a Dutch outfit that provides a European authorized representative service to firms in China and other non-EU countries, is listed alongside SML in the contact section.