This is the software correction for the Local Run Manager security vulnerability of which customers were informed and a temporary security patch was provided in May 2022.
The following table lists the impacted instruments and the required actions for each instrument. Note that all prior versions of control software which utilize Local Run Manager will no longer be available for distribution by Illumina once the software versions listed below are released.
Upon completion of the successful software upgrade, follow Illumina Cybersecurity best practices, including confirming that the firewall is enabled, and Universal Copy Service is running as a standard user.
| Instrument | Action | Release Date |
|---|---|---|
| iScan | None | N/A |
| iSeq 100 | User to update to iSeq Control Software v3.1 and available Local Run Manager modules (Refer to Additional Information below). | March 13, 2024 |
| MiniSeq | User to update to Miniseq Control Software v2.3 and available Local Run Manager modules (Refer to Additional Information below). | March 13,2024 |
| MiSeq | User to update to MiSeq Control Software v4.1 and available Local Run Manager modules. (Refer to Additional Information below.) | November 28, 2023 |
| MiSeqDx | Illumina Field Support to update to MiSeqDx Operating Software v4.1 and available Local Run Manager modules. (Refer to Additional Information below.) | November 28, 2023 |
| NextSeq 500 / NextSeq 550 | Illumina Field Support to update NextSeq Control Software v4.2 and available Local Run Manager modules. (Refer to Additional Information below.) | May 31, 2023 |
| NextSeq 550Dx | Illumina Field Support to update NextSeqDx Operating Software v1.7 and available Local Run Manager modules (Refer to Additional Information below.) | October 25, 2023 |
| NextSeq 1000 / NextSeq 2000 | None | N/A |
| NovaSeq 6000 | None | N/A |
| NovaSeq 6000Dx | None | N/A |
| NovaSeq X | None | N/A |
NOTE: MyIllumina log-in is required. For MyIllumina log-in support, contact Illumina Customer Care.
| MiSeq Module | Compatible Version with MiSeq Control Software v4.1 | Availability |
|---|---|---|
| 16s Metagenomics |
v2.0.0.5 | Modules available on the Illumina Support Site. |
| Amplicon DS | v3.0.0.56 | |
| Assembly | v2.0.1.2 | |
| DNA Amplicon | v3.0.1.1 | |
| DNA Enrichment | v3.1.0.1090 | |
| GenerateFASTQ | v3.1.0.35 | |
| Library QC | v2.2.0.17 | |
| PCR Amplicon | v2.0.0.3 | |
| Resequencing | v3.0.1.13 | |
| RNA Amplicon | v3.0.0.26 | |
| RNA Fusion | v3.0.0.25 | |
| Small RNA | v3.0.0.24 | |
| TruSight Tumor (TST15) | TBD | Planned for Q2 2024 |
Refer to the following editable PDFs of the recall verification forms. Return the completed form to techsupport@illumina.com to acknowledge receipt of the notification and completion of software update.
| MiSeqDx Module | Compatible Version with MiSeqDx Control Software v4.1 | Availability |
|---|---|---|
| CF 139-Variant 2.0 |
v1.0.1.124 | Installed by Illumina Field Representative. |
| CF 139-Variant 2.0 Micro | v1.0.0.113 | |
| CF Clinical Seq 2.0 | v1.0.1.96 | |
| CF Clinical Seq 2.0 Micro | v1.0.0.70 | |
| DNA GenerateFASTQ Dx | v1.0.0.299 | |
| Germline Variant | v2.0.0.36 | |
| Somatic Variant | v2.0.0.12 |
| NextSeq 550 Module Description | Compatible Version with NextSeq Control Software v4.2 | Availability |
|---|---|---|
| 16s Metagenomics |
v2.0.0.5 | Modules available on the Illumina Support Site. |
| Amplicon DS | v3.0.0.56 | |
| Assembly | v2.0.1.2 | |
| DNA Amplicon | v3.0.1.1 | |
| DNA Enrichment | v3.1.0.1090 | |
| GenerateFASTQ | v3.1.0.35 | |
| Library QC | v2.2.0.17 | |
| PCR Amplicon | v2.0.0.3 | |
| Resequencing | v3.0.1.13 | |
| RNA Amplicon | v3.0.0.26 | |
| RNA Fusion | v3.0.0.25 | |
| Small RNA | v3.0.0.24 | |
| TruSight Oncology 500 | v2.3 | Planned for Q3 2023 |
| VeriSeq NIPT | v1.0.4.3 | Planned for Q4 2023 |
| NextSeq 550Dx Module | Compatible Version with NextSeq 550Dx Operating Software v1.7 | Availability |
|---|---|---|
| DNA GenerateFASTQ Dx | v1.0.0.299 | Modules available on the Illumina Support Site. |
| Germline Variant | v1.3.0.0 | |
| Somatic Variant | v1.3.0.0 | |
| VeriSeq NIPT | v1.1.2.601 | |
| TruSight Oncology Comp IVD | v2.3.7 (IVDD) | Planned for Q4 2023 |
Refer to the following editable PDFs of the recall verification forms. Return the completed form to techsupport@illumina.com to acknowledge receipt of the notification.
| Form | Description |
|---|---|
| FSN2023-1450 NextSeqDx Local Run Manager Update - Verification | Verification Form: Standard Form |
| Product Defect Correction Notice (RC-2023-RN-00842-1) | Verification Form: Australia |
| PQN2023-1451 NextSeqDx Local Run Manager Update for Japan and Korea-Verification | Verification Form: Japan and Korea |
| FSN2023-1450 NextSeqDx Local Run Manager Update - NZ -Verification | Verification Form: New Zealand |
| FSN2023-1450 NextSeqDx Local Run Manager Update for Portugal – Verification | Verification Form: Portugal |
| FSN2023-1450 NextSeqDx Local Run Manager Update Singapore-Verification | Verification Form: Singapore |
NOTE: MyIllumina log-in is required. For MyIllumina log-in support, contact Illumina Customer Care.
For instruments under an Advanced Exchange Support Plan, onsite field service is not available.
| iSeq Module | Compatible Version with iSeq Control Software v3.1 | Availability |
|---|---|---|
| 16s Metagenomics |
v2.0.0.5 | Modules available on the Illumina Support Site. |
| Amplicon DS | v3.0.0.56 | |
| Assembly | v2.0.1.2 | |
| DNA Amplicon | v3.0.1.1 | |
| DNA Enrichment | v3.1.0.1090 | |
| GenerateFASTQ | v3.1.0.35 | |
| Library QC | v2.2.0.17 | |
| PCR Amplicon | v2.0.0.3 | |
| Resequencing | v3.0.1.13 | |
| RNA Amplicon | v3.0.0.26 | |
| RNA Fusion | v3.0.0.25 | |
| Small RNA | v3.0.0.24 |
Refer to the following editable PDFs of the recall verification forms. Return the completed form to techsupport@illumina.com to acknowledge receipt of the notification.
NOTE: MyIllumina log-in is required. For MyIllumina log-in support, contact Illumina Customer Care.
| MiniSeq Module | Compatible Version with MiniSeq Control Software v2.3 | Availability |
|---|---|---|
| 16s Metagenomics |
v2.0.0.5 | Modules available on the Illumina Support Site. |
| Amplicon DS | v3.0.0.56 | |
| Assembly | v2.0.1.2 | |
| DNA Amplicon | v3.0.1.1 | |
| DNA Enrichment | v3.1.0.1090 | |
| GenerateFASTQ | v3.1.0.35 | |
| Library QC | v2.2.0.17 | |
| PCR Amplicon | v2.0.0.3 | |
| Resequencing | v3.0.1.13 | |
| RNA Amplicon | v3.0.0.26 | |
| RNA Fusion | v3.0.0.25 | |
| Small RNA | v3.0.0.24 | |
| TruSight Tumor (TST15) | TBD | Planned for Q2 2024 |
Refer to the following editable PDFs of the recall verification forms. Return the completed form to techsupport@illumina.com to acknowledge receipt of the notification.