Illumina, Inc. Illumina NextSeq 550Dx, REF: 20005715, CE, IVD Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Brand
Illumina, Inc.
Lot Codes / Batch Numbers
Lot #s NDX550110 - NDX550843, UDI: (01)00816270020125
Products Sold
Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Illumina, Inc. is recalling Illumina NextSeq 550Dx, REF: 20005715, CE, IVD due to There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, LA, MD, MI, MN, NE, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV
Page updated: Jan 10, 2026