Illumina, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0854-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Product Classification:

Class II

Date Initiated: February 22, 2022

Date Posted: April 6, 2022

Recall Number: Z-0854-2022

Event ID: 89699

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.

Status: Completed

Product Quantity: 674 instruments

Code Information:

Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated