Certain lots of SD Biosensor’s Pilot COVID-19 At-Home Test are being recalled because of significant concerns of bacterial contamination in the liquid solution provided in the test kit.
According to the Food and Drug Administration (FDA), organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species may be present in the liquid solution. These kits were distributed by Roche Diagnostics to certain retailers in the US, including roughly 500,000 tests to CVS Health and 16,000 tests to Amazon.
Consumers in possession of tests with the affected lot numbers should dispose of them. The entire test kit should be thrown in the trash. The liquid solution should not be poured down the drain.
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As the contamination may impact the performance of the test, health care providers who used the Pilot COVID-19 At-Home Test within the past 2 weeks should consider retesting patients with another SARS-CoV-2 diagnostic test if an inaccurate result is suspected.
Additionally, for patients who present with signs of bacterial infection, conjunctivitis, or other signs of systemic infections, an inquiry should be made as to whether the Pilot COVID-19 At-Home Test was recently used. If so, the infection may potentially be related to exposure to the contaminated buffer solution.
At this time, there have been no reports of adverse events related to the use of the SD Biosensor Pilot COVID-19 At-Home Test. The FDA is in the process of classifying this recall and is working with the Company to resolve the problem.
Reference
Do not use certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA safety communication. News release. May 4, 2023. Accessed May 8, 2023. https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication.
This article originally appeared on MPR
