More than half a million DIY Covid tests have been recalled by the US Food and Drug Administration (FDA), which said it had “significant concerns of bacterial contamination” in some SD Biosensor Pilot Covid-19 At-Home Tests.
Apart from safety concerns, using the contaminated solution could also cause inaccurate results, said the FDA, warning people to throw away the tests immediately.
More than 500 000 tests were distributed to the CVS drugstore and around 16 000 were distributed to Amazon, reports the BBC.
The liquid in the test kits was found to be contaminated “with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species” that could cause illness for people with weakened immune systems, the FDA said.
Evie Baik, a spokesperson for SD Biosensor, said the raw materials from one of their suppliers was the probable source of the bacteria. The company had cut ties with that supplier and was tightening quality control efforts, she added.
SD Biosensor and distributor Roche are working with distributors and retailers to hold back tests while the matter is being investigated.
BBC article – US FDA recalls over 500,000 Covid tests over bacteria risk (Open access)
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