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U.S. Department of Health and Human Services

Class 2 Device Recall NextSeq 550Dx

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  Class 2 Device Recall NextSeq 550Dx see related information
Date Initiated by Firm February 22, 2022
Create Date March 31, 2022
Recall Status1 Open3, Classified
Recall Number Z-0854-2022
Recall Event ID 89699
Product Classification High throughput DNA sequence analyzer - Product Code PFF
Product Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Code Information Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Recalling Firm/
Manufacturer		 Illumina, Inc.
5200 Illumina Way
San Diego CA 92122-4616
For Additional Information Contact Karen Gutekunst
858-255-5541
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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