Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Illumina, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Product Codes/Lot Numbers:
Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0854-2022
Related Recalls
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Cybersecurity vulnerability concerning the software used for sequencing instruments.