December 4, 2022

Medical Trend

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Illumina recalls 1813 sequencers worldwide

Illumina recalls 1813 sequencers worldwide



 

Illumina recalls 1813 sequencers worldwide. 


On the 13th, the US FDA’s official website issued a medical device recall notice, requiring illumina to recall 1,813 sequencers globally.

 

Illumina recalls 1813 sequencers worldwide

Screenshot of FDA official website

 

The FDA says the sequencers have secondary safety concerns, meaning that the recalled medical device products may cause temporary or reversible health problems, or have a certain chance of causing serious health problems or death.

 

Illumina recalls 1813 sequencers worldwide

Screenshot of NATIONAL LIBRARY OF MEDICINE official website

 

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, the number is 1014.

 

The FDA has previously publicly warned of information security vulnerabilities in many of Illumina’s sequencers.

In an open letter, the FDA detailed a serious flaw in the illumina sequencer software, and further pointed out that the flaw could allow unauthorized users to remotely gain control of the sequencer, modify the sequencer’s configuration, software, and data in the sequencer network , modify or damage the clinical diagnosis results of the sequencer and provide false results.

The FDA said it is working with illumina and coordinating with CISA to identify, communicate and prevent adverse events related to this cybersecurity breach.

 

Illumina is a world-renowned gene sequencing company. According to the data from the Prospective Research Institute, illumina accounts for 83.9% of the global gene sequencing market.

Affected by FDA warnings and other events, it fell 9.64% to US$202.82 as of the press date, with a total market value of US$31.9 billion.

 

 

 

 

Illumina recalls 1813 sequencers worldwide

(source:internet, reference only)


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