(WHTM) — The US Food and Drug Administration is warning consumers and healthcare providers to stop using and to throw out certain lots of recalled at-home COVID-19 tests.
The FDA states that the recall affects SD Biosensor Inc. Pilot COVID-19 at-home tests, which are distributed by Roche Diagnostics.
The FDA says this has to do about bacterial contamination within the liquid solution of the test kit. The FDA also states that direct contact with the contaminated liquid could cause a safety concern and may affect the outcome of the test.
The FDA mentions that none of the impacted tests were distributed through the US government’s Free at Home COVID-19 tests program.
The company has started a recall for impacted tests to certain retailers in the United States. The FDA says around 500,000 tests were distributed to CVS Health and 16,000 were distributed to Amazon.
Below is a list of lots numbers of tests that have been affected by the possible contamination, which has been provided by the FDA.
The FDA is advising people that have the tests with the lot numbers mentioned above to throw the entire test in the household trash and not pour the liquid in the drain.
In addition to the risk of infection, the contamination may result in false results, which include false positive and false negative results.
Anyone with questions can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.