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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92233

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 05, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Illumina, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

Z-1976-2023
Recall number
Z-1976-2023
Initiated
April 05, 2023
Classification
Class II
Status
Completed
Recalling firm
Illumina, Inc.
Quantity
1067 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Cybersecurity vulnerability

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Code information

Impacted UCS Versions: 1.4.2.927, 1.6.3.1423, 2.7.2.4320/ UDI-DI: (00)816270020125

Distribution pattern

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.

device · product 2 of 2

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

Z-1977-2023
Recall number
Z-1977-2023
Initiated
April 05, 2023
Classification
Class II
Status
Completed
Recalling firm
Illumina, Inc.
Quantity
740 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Cybersecurity vulnerability

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Code information

UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002

Distribution pattern

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.