NEW YORK – The US Food and Drug Administration announced on Friday E25Bio is recalling its COVID-19 Direct Antigen Rapid Test and Base10 Genetics is recalling its RNAstill MTM specimen collection kit.
Both are Class I recalls, the highest of three classes of FDA recalls. Such recalls are issued when there is a reasonable probability that use of the product could cause serious health consequences or death.
E25Bio's antigen test is being recalled because it was marketed and distributed in the US without authorization, clearance, or approval from the FDA, the agency said in a notice on its website. Labeling for some of the tests also included inaccurate claims and instructions. The FDA noted that there is not enough data supporting the test's performance, which could lead to false results.
E25Bio recommended customers destroy the tests, while the FDA recommended test users talk to their healthcare providers if they were tested with the E25Bio test and are concerned about test results. The FDA also recommended healthcare providers retest patients who were tested with the assay in the past two weeks if an inaccurate result is suspected.
Earlier this month, the FDA issued a warning against using E25Bio's tests.
The Base10 specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples to be tested for viruses, including SARS-CoV-2 and influenza, and bacteria, the FDA said in the recall notice posted to its website.
The collection kits were recalled because they were distributed without proper premarket clearance from the FDA, so there is not enough data available about the product to know how well it inactivates and stabilizes a virus for transport and storage. If the specimens aren't stored correctly, it could lead to false negative results or the virus spreading to people in the lab.
The kits were distributed to long-term care facilities where staff may not have been trained to handle the transport medium of the kit, which contains a hazardous chemical requiring special training, the FDA said on its website.
The company and agency recommend discontinuing use and returning the unused product. The agency noted that the medium shouldn't come into contact with bleach or other oxidizing agents, or acidic or alkaline products in order to prevent the release of toxic gases.