Z-1977-2023Class II

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software

Name: Z-1977-2023 MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software
Creator: Illumina, Inc.
Published: 2023-04-05
License: https://open.fda.gov/license/

Illumina, Inc. / initiated 2023-04-05 / Completed / root cause: software

FDA source

Illumina, Inc. began a recall of MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software on 2023-04-05. FDA classified it as Class II and gives the reason as "Cybersecurity vulnerability concerning the software used for sequencing instruments". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1977-2023
Classification: Class II
Status: Completed
Initiated: 2023-04-05
Posted: 2023-06-16
Recalling firm: Illumina, Inc.
Product: MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Product code: PFF High Throughput Dna Sequence Analyzer
Reason for recall: Cybersecurity vulnerability concerning the software used for sequencing instruments.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1977-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1976-2023	Class II	Completed	Voluntary: Firm initiated	2023-06-28	2023-06-16
Z-1977-2023	Class II	Completed	Voluntary: Firm initiated	2023-06-28	2023-06-16

Product code PFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)