# FDA recall Z-0854-2022

> **Illumina, Inc.** · Class II · device recall initiated 2022-02-22.

## Product

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

## 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.

## 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

## Key facts

- **Recall number:** Z-0854-2022
- **Recalling firm:** Illumina, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-02-22
- **Report date:** 2022-04-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0854-2022

## Citation

> AI Analytics. FDA recall Z-0854-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0854-2022. Source: US FDA. Licensed CC0.

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