SD BioSensor has recalled certain Pilot COVID-19 At-Home Test kits over concerns of bacterial contamination.
The in vitro diagnostics company has recalled a total of 2,712,767 tests in the US, which were distributed by Roche Diagnostics.
The action was taken after it was found that the liquid solution in the test kits is anticipated to be contaminated with bacteria such as enterobacter, enterococcus, serratia and klebsiella.
The FDA has categorised the action as a Class I recall, which signifies the highest level of recall due to the potential for severe injuries or even death if the affected devices are utilised.
The bacterial contamination may cause an infection that may result in illness in individuals with weakened immune systems. Direct contact with the contaminated liquid could potentially lead to safety issues.
Furthermore, the contamination will also affect the performance of the test and lead to false results.
To date, SD BioSensor has not received any complaints or reports of injuries, adverse events or deaths.
During the first week of May, the company issued an advisory urging consumers to discontinue the use of certain Pilot COVID-19 At-Home Tests and appropriately discard the entire testing kit in household waste.
The company’s Pilot COVID-19 At-Home Test is a lateral flow immunoassay device designed to qualitatively identify the nucleocapsid protein antigen in the SARS-CoV-2 virus.
The usage of this test is approved for non-prescription home use for individuals aged 14 years and above. It is designed for self-collection of anterior nasal (nares) swab samples. Adults can use the device to collect the swab samples from individuals aged two years and above.