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U.S. Department of Health and Human Services

Class 2 Device Recall MiSeq Dx Instrument

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  Class 2 Device Recall MiSeq Dx Instrument see related information
Date Initiated by Firm April 05, 2023
Date Posted June 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-1977-2023
Recall Event ID 92233
Product Classification High throughput DNA sequence analyzer - Product Code PFF
Product MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Code Information UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
Recalling Firm/
Manufacturer		 Illumina, Inc.
5200 Illumina Way
San Diego CA 92122-4616
For Additional Information Contact David McAlpine
347-327-1336
Manufacturer Reason
for Recall		 Cybersecurity vulnerability concerning the software used for sequencing instruments.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action On April 5, 2023, Illumina issued a "Urgent Medical Device Recall" Notification via XXX. Illumina ask consignees to take the following actions: 1. Download & Install Software Patch: For Each Instrument Connected to the Internet: 2. Change UCS User Configuration(s): Change the UCS User configuration to standard user (with no administrator permissions) by following the instructions available in the customer communication. 3. Complete and return the Verification Form after carrying out all the steps in the instructions provided on your specific instrument(s) identified as affected in Table 1. 4. If you experience an adverse event due to this vulnerability with the use of any of the affected products, please report it to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. You can complete and submit the report online at www.fda.gov/medwatch/report.htm.
Quantity in Commerce 740 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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