The US Food and Drug Administration (FDA) issued a medical device recall notice on Monday, requiring US life sciences company Illumina to recall 1,813 sequencers worldwide, including the Chinese market, over a "cybersecurity vulnerability."

All the recalled equipment are clinical-grade sequencers with qualitative safety "class 2" issued by the FDA.

"The clinical-use gene sequencer can be used for tumor detection in hospitals and fertility gene screening. It also has applications in disease control, for instance, to trace and monitor a chain of coronavirus samples," an industry insider, who asked to remain anonymous, told the Global Times on Tuesday.

The wide application of data means that once leaked, it may endanger public health, national security and public interests, the expert said.

Previously, US regulators warned healthcare providers about a cybersecurity risk with some Illumina DNA-sequencing machines that could compromise patient data, according to a Bloomberg report on June 3.

Several of Illumina's next-generation machines have a software vulnerability that could allow an unauthorized user to take control of the system remotely and alter settings or data, the FDA said in a letter. While there have been no reports of this happening, it is possible that a hacker could alter a patient's clinical diagnosis or gain access to sensitive genetic information.

The FDA said an unauthorized user could exploit the vulnerability by taking control of the instrument remotely, alter settings, configurations, software, or data on the instrument or customer's network. Additionally, hackers could impact patient test results by making the machine to provide incorrect, altered results or none at all. There is also the potential for data breach.

In response to the report, Illumina said in a statement that its team has "developed a software patch to protect against remote exploitation of this vulnerability. In addition to this patch, we are working to provide a permanent software fix for current and future instruments and will notify customers directly when it is available."

Illumina has a near monopoly on the genetic-sequencing market and its machines are used for both research and in medical practice, Bloomberg said.