Recall Z-0854-2022 ยท PFF High Throughput Dna Sequence Analyzer
Illumina, Inc.
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
| Date | Feb 22, 2022 |
| Status | Completed |
| 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 Illumin |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.