Health product recall

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

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