Illumina Recalls 1,813 Gene Sequencers Globally Including MiSeq Dx Units in China Due to Cybersecurity Vulnerabilities

On the 13th, the U.S. FDA website issued a medical device recall notice, requesting Illumina to recall 1,813 sequencing instruments globally. The products involved in the Chinese market are Illumina REF 20014053 Model: MiSeq Dx.

Screenshot of the FDA website

FDA states that these sequencers have a Class II safety issue, meaning the recalled medical device products may cause temporary or reversible health problems, or have a certain probability of causing serious health issues or death.

NATIONAL LIBRARY OF MEDICINE Official Website Screenshot

The recalled sequencers include: Illumina Model NextSeq 550 Dx REF 20005715, with a quantity of 799 units. Illumina REF DX-410-1001 Model: MiSeq Dx; Illumina REF 15036706 Model: MiSeq Dx; Illumina REF 20014053 Model: MiSeq Dx, with a total quantity of 1014 units.

Previously, the FDA issued a public warning about serious security vulnerabilities in multiple Illumina sequencing instruments. In its official communication, the FDA provided detailed information regarding significant flaws in the software of Illumina sequencers, further noting that these flaws could allow unauthorized users to remotely gain control of the devices. This access could enable malicious actors to alter the configuration and software of the sequencers, manipulate data within the sequencing network, modify or corrupt clinical diagnostic results, and even generate falsified outcomes. The FDA stated that it is actively collaborating with Illumina and coordinating with CISA to identify, communicate, and mitigate adverse events arising from this cybersecurity vulnerability.

Illumina is a globally renowned gene sequencing company. According to data from the前瞻研究院(Forward-looking Research Institute), Illumina accounts for 83.9% of the global gene sequencing market share. Affected by events such as the FDA warning, as of the date of this report, its stock price fell by 9.64%, closing at $202.82, with a total market value of $31.9 billion.

Source | People's Daily Health Client