NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Summary
The FDA issued a Class II for NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service s by Illumina, Inc.. Reason: Cybersecurity vulnerability concerning the software used for sequencing instruments..
Details
Source
Device Recall
External ID
Z-1976-2023
Action Date
2023-06-28
Status
Completed
Category
device
Product Description
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Lot/Code Info: Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125
Quantity Affected: 1067 units
Reason for Recall
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, AU Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Egypt, FR France, GB Georgia, Germany, Guatemala, Hong Kong, Hungary, IT Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Fed., Saudi Arabia, SG Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd. Arab Emir., Vietnam, Argentina, Aerbaijan, Belgium, Bosnia-Herz., Finland, Greece, Iceland, Ireland, Israel, Japan, Nigeria, NL Norway, Romania, Serbia, Slovakia, South Africa, T¿rkiye, Ukraine.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-05
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 246 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Illumina, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Illumina, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Illumina, Inc. have FDA actions?
Illumina, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1976-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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