FDA Medical Device Recalls (openFDA)
Illumina, Inc.: Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- Recall number
- Z-0854-2022
- Recalling firm
- Illumina, Inc.
- Product
- Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- Status
- Completed
- Initiated
- 2022-02-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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 techsupport@illumina.com 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 techsupport@illumina.com 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.
- Quantity
- 674 instruments
- 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
- Lot, serial or model codes
- Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PFF
- Firm FEI
- 3003218906
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28