CLASS II Device recall · Reported 28 Jun 2023 · FDA Enforcement Report
MiSeq Dx Instrument recalled by Illumina
Illumina is recalling MiSeq Dx Instrument, distributed nationwide in the US. The recall was initiated on 5 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1977-2023
- FDA event ID
- 92233
- Recalling firm
- Illumina, San Diego, CA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 5 Apr 2023
- FDA classified
- 16 Jun 2023
- Reported
- 28 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 5 Apr 2023 | Recall initiated by company | |
| 16 Jun 2023 | Classified by FDA | +72 days |
| 28 Jun 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Which lots are affected?
UCS Versions: UCS 2.5.0/ UDI-DI: (00)816270020002
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92233| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NextSeq 550Dx Instrument recalled by Illumina | Illumina | Device Malfunction | Nationwide |
More recalls from Illumina
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NovaSeq 6000Dx including Dragen Server recalled by Illumina | Illumina | Potency & Assay | Nationwide |
| Device | CLASS II | Reagent Kits/ containing flow cells recalled by Illumina | Illumina | Potency & Assay | Nationwide |
| Device | CLASS II | NextSeq 550Dx Instrument recalled by Illumina | Illumina | Device Malfunction | Nationwide |
| Device | CLASS II | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model recalled | Illumina | Other | Nationwide |
| Device | CLASS II | illumina Model NextSeq 550 Dx REF recalled | Illumina | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |