FDA Provides Update on Illumina’s Recall of Its DNA Analyzer

The FDA has issued on update on Illumina’s May 3 recall of its high-throughput DNA sequence analyzer, deeming it a Class 2 recall.

The reason for the recall is a cybersecurity vulnerability. The problem affects 1,014 of Illumina’s NextSeq 550 Dx and MiSeq Dx instruments, with software versions 1.3 to 3.1 of the Local Run Manager (LRM) software installed.

Illumina has developed a software patch that can be downloaded through a secure portal to protect against hackers. Installation of the software patch will block remote access to the LRM web user interface, the agency said.