Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29335 |
| Brand Name: | Illumina_IVD_NextSeq 550Dx Instrument (20005715) |
| Model: | MiSeqDx Instrument |
| Affected: | Catalog Number DX-410-1001 |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | Illumina Inc |
| Issue: | The manufacturer has released a new software version that remediates the cybersecurity vulnerability and restores remote access to the LRM Web User Interface. New versions of the NextSeq Operating Software (NOS) v1.7.0 and NextSeq Control Software (NCS) v4.2.0, which both include Local Run Manager (v4.1.0 and v4.0.0, respectively), are available for installation on the NextSeq 550Dx instruments. Update 5/10 2023: In May 2022, Illumina contacted customers regarding a Local Run Manager (LRM) cybersecurity vulnerability which included the NextSeq™ 550Dx instruments. The manufacturer is following up regarding the Local Run Manager (LRM) cybersecurity vulnerability. This information outlines the issue summary, Illumina's actions, and required customer actions. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/10/2023 |
