Illumina NextSeq 550Dx recall
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Why was Illumina NextSeq 550Dx 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
- Product
- Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
- Recalling firm
- Illumina, Inc.
- 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
- Recall date
- April 6, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)