A manufacturer is recalling over half a million COVID-19 test kits distributed to CVS and Amazon due to possible contamination with bacteria strains that can cause illness, according to the US Food and Drug Administration (FDA).
The contaminated kits may also produce false results, posing a risk to individuals who may receive inaccurate diagnoses.
The FDA has not received reports of anyone developing illness from using the test kits. Nevertheless, the agency is urging consumers to stop using and discard any test kits that may be part of the recall, without pouring the liquid solution down the drain.
The kits, labeled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, were distributed by Roche Diagnostics. The FDA has provided lot numbers of the affected test kits on its recall notice, and consumers can obtain more information from the notice.
Approximately 500,000 kits were distributed to CVS, and around 16,000 to Amazon. However, these were not among those distributed for free by the federal government.
According to the FDA, the liquid in the test kits could be contaminated with several strains of bacteria, including Enterococcus, Enterobacter, Klebsiella, and Serratia species. While consumers are not supposed to ingest or come into contact with the liquid during the normal testing process, accidental exposure is possible, the agency notes.
People with weakened immune systems or those with direct exposure to the contaminated liquid solution through standard handling, accidental spills, or misuse of the product may develop illness from bacteria such as Enterococcus, Enterobacter, Klebsiella, and Serratia species, warns the FDA.
The recall of the COVID-19 test kits is yet another blow to the US testing efforts as the country continues to grapple with the pandemic. The highly infectious nature of COVID-19 has led to the development of several diagnostic tests, but it has also opened the door to unscrupulous manufacturers trying to cash in on the pandemic.
With an increasing number of people relying on at-home test kits for COVID-19, there is a greater need for regulatory oversight to ensure the safety and accuracy of the test kits. The recall of these test kits should serve as a wake-up call for the industry and regulators to put in place robust quality control measures to prevent the distribution of defective products.
While the FDA is working to ensure that the recalled test kits are removed from the market, it also urges consumers to be vigilant when purchasing at-home test kits for COVID-19. The agency advises consumers to only use test kits that have been authorized by the FDA, and to report any adverse reactions or problems with the product to the agency.
The he recall of over half a million COVID-19 test kits due to possible bacterial contamination highlights the need for greater regulatory oversight of the at-home testing market. The FDA’s recall notice serves as a reminder to consumers to be vigilant when purchasing at-home test kits and to only use authorized products. The safety and accuracy of these products are critical in the fight against the pandemic, and the industry and regulators must work together to ensure that defective products do not make it into the hands of consumers.