MiSeq Dx Instrument, Catalog # M70101, containing Universal… recallZ-1977-2023 · Illumina, Inc. · initiated Apr 5, 2023
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Illumina, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cybersecurity vulnerability concerning the software used for sequencing instruments.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
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.
Recall details
- Recall number
- Z-1977-2023
- Status
- Completed
- Initiated by the company
- Apr 5, 2023
- Posted by the FDA
- Jun 16, 2023
- Recalling firm
- Illumina, Inc.
- Quantity
- 740 units
- Product code
- PFF
- 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.
Product description
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Code information (models, lots, serial numbers)
UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MiSeqDx Instrument 15036706Illumina, Inc. · High Throughput Dna Sequence Analyzer2 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 92233).
- Z-1976-2023 · CompletedNextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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