Yesterday, the FDA issued a new safety communication warning against the use of the Skippack Medical Lab (SML) SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). The test hasn’t received FDA authorization, clearance, or approval.
SML Distribution LLC is recalling the test, which uses a nasal swab sample to detect proteins known as antigens that are secreted by the body to fight the SARS-CoV-2 virus. The FDA has labeled the recall a Class I, the most serious kind. Although the FDA hasn’t received reports of injuries or deaths related to its use, the Colloidal Gold test poses relatively high risks of both false positive and negative results, the agency warns.
This is the second Class I recall for a COVID-19 test announced in the past two days. Yesterday, the agency said that it has classified Mesa Biotech’s recent recall of its Accula SARS-CoV-2 PCR test as a Class I due to risk of false positive results and serious injury or death. On April 6, Mesa Biotech sent a recall letter to customers who had received certain lots of the kit potentially tainted by contamination in the manufacturing facility warning them not to use the product and to trash any kits they might have in inventory.
At the end of last month, the agency also labeled the recent recall of Celltrion USA’s Celltrion DiaTrust COVID-19 Ag Rapid Tests as a Class I recall.