Illumina NextSeq 550Dx, REF: 20005715, CE, IVD recallZ-0854-2022 · Illumina, Inc. · initiated Feb 22, 2022
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
There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
FDA root cause category: Device Design
What the company is doing
On February 22, 2022 Illumina issued a "Urgent Field Safety" recall notice to all affected consignees via E-Mail. The firm issued an amended "Urgent Medical Device" recall notice on March 11, 2022 via email to provide consignees with additional information. In addition to notifying consignees about the recall, the firm asked consignees to take the following actions: 1. Complete the attached FSN2022-125 verification form to confirm receipt of the notification and return the form to Technical Support at [email protected] within 5 business days. 2. If you have not already sent Illumina the Verification Form attached to FSN2022-1215, please complete the attached copy of the form and return it to Technical Support at [email protected] within 5 business days. No additional action is required at this time 3. Please note, if an operator experiences an adverse event with the use of this product, user may report this to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Recall details
- Recall number
- Z-0854-2022
- Status
- Completed
- Initiated by the company
- Feb 22, 2022
- Recalling firm
- Illumina, Inc.
- Quantity
- 674 instruments
- Product code
- PFF
- Distribution
- US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom Vietnam
Product description
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Code information (models, lots, serial numbers)
Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NextSeq 550Dx Sequencing System 20005715Illumina, Inc. · High Throughput Dna Sequence Analyzer4 recalls3 reports
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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