NextSeq™ 550Dx and MiSeq™Dx Instruments
Brand(s)
Last updated
Summary
Product
NextSeq™ 550Dx and MiSeq™Dx Instruments
Issue
Medical devices - Performance
What to do
Instructions to be provided by manufacturer on how to correct situation.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| MiSeq™Dx Instrument | M70286-15037414 M70292-15037414 M70335-15037414 M70553-15037414 M70546-15037414 M70293-15037414 M70444-15037414 M70349-15037414 M70552-15037414 M70440-15037414 M71207-20014737 | DX-410-1001 |
| NextSeq™ 550Dx Instrument | NDX551031-15073937 NDX551020-15073937 NDX551316-15073937 | 20005715 |
Issue
A security vulnerability associated with the Dragen server was discovered. The vulnerability is such that, if a customer network is not properly secured, the communications between the instrument (universal copy service software) and the customer network storage is susceptible to potential interception and modification.
Recall start date: May 8, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - Chemistry
Companies
Illumina, Inc.
5200 Illumina Way, San Diego, California, United States, 92122
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75789
Get notified
Receive notifications for new and updated recalls and alerts by category.