Device recall: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog…
Class II FDA enforcement event 99585. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Illumina, Inc. started this device recall on 17 Sep 2024. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class II. FDA event 99585 has 1 product record. The first FDA enforcement report date is 7 Oct 2026. The record gives the status Ongoing. 371 of the 971 device events that started in 2024 have more product records. The median device event of 2024 has 1 product record. The openFDA file has 971 device events that started in 2024 and 917 that started in 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT, KA, MA, NJ, MD and the countries of Spain, South Korea, Japan, Australia, Italy, United Arab Emirates, Sweden, United…
Recalling firm
Illumina, Inc., San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0068-2027 | NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130 | 80 | Class II | Ongoing | 7 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 971
- Share of these events in Class II
- 87%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 8
Other events of the firm
Official channels
- FDA enforcement report Z-0068-2027The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99585. https://recallregister.com/fda/ii/99585/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide - US Nationwide distribution in the states of TX, KS, NC, CA, UT, KA, MA, NJ, MD and the countries of Spain, South Korea, Japan, Australia, Italy, United Arab Emirates, Sweden, United…
- What quantity of product is in FDA event 99585?
- The FDA record gives this quantity:
80
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 971 device events that started in 2024 are in Class II.