FDA Warns That Over 500K Covid Test Kits Should Be Thrown Out Due To Bacteria Risk
The FDA has warned that more than half a million Covid tests should be disposed of due to “significant concerns” over bacterial contamination.
The covid tests are being recalled due to the presence of possibly dangerous bacteria in the liquid solution.
The FDA said that the tests may be contaminated with bacteria such as enterococcus, enterobacter, klebsiella and serratia species and cause infection particularly in people with weakened immune systems.
According to TGP: In a recall announcement made this week, SD Biosensor, Inc. said that more than 40 batches of its Pilot COVID-19 At-Home Tests were affected.
The U.S. Food and Drug Administration has stated that roughly 500,000 of the recalled tests were delivered to CVS Health and around 16,000 were sent to Amazon.
The contaminated kits may also produce false test results.
10TV reported:
The FDA stressed that none of the recalled lots were distributed through federal testing programs or through COVID.gov.
The affected tests can be identified by the lot number on the outer packaging and should be thrown in the trash. If you have one of the recalled tests, you are urged not to pour the liquid down any household drains.
The potentially harmful bacteria was found in the test tube with liquid inside (pouch 2 of the kits), according to the recall announcement. It notes that while the liquid is contained in a sealed tube, direct exposure to the liquid through misuse or spillage could potentially lead to serious illness.
Additionally, the FDA said the contamination may impact the test performance and cause false-negative or false-positive results.
Consumers can see a full list of recalled lots below or look up their test kit’s lot number on this website, which will indicate whether a particular test kit may be used or should be properly disposed of.
Consumers may also contact the Roche Customer Support Center at 1-866-987-6243 and select option 1. If a consumer’s test kit is from an unaffected lot, it is safe to continue using tests from that kit in accordance with the instructions for use, which can be found in the test kit or at go.roche.com/covid-home-test.
