Media Update, page-1434

These Biotime tests are contraversial. Used in the UK. FDA warning in the US.

( April 2021 )
Most of the company’s tests are manufactured by Xiamen Biotime Biotechnology in Xiamen, China, and the FDA’s inspection found that Innova’s quality assurance of these imported tests was inadequate. Following the FDA’s inspection, Innova initiated a recall of more than 77,000 tests in April, and the company says that it is still working to fully comply with FDA requirements.
( August 2021)
The FDA maintains Innova’s COVID-19 lateral flow test included labeling that provided “false and misleading” estimates of the test’s clinical performance.