The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0854-2022·Announced 2022-04-06

Illumina NextSeq 550Dx DNA Analyzer Recalled for Short Circuit Risk

Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with a known functional defect that renders the analyzer inoperable. Although no injuries have been reported, the device's critical role in genetic diagnosis represents a risk-of-harm situation where diagnostic disruption is possible.

Plain-English summary

Illumina, Inc. is recalling 674 NextSeq 550Dx DNA sequence analyzers (Model REF: 20005715, CE, IVD) due to a potential short circuit. The short circuit may occur shortly after disconnecting and reconnecting the circuit board or imaging module if the ribbon cable is not sufficiently reconnected. When this occurs, the analyzer becomes inoperable.

The affected analyzers were distributed in the United States across multiple states and internationally to 27 countries including 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, and Vietnam. The recall involves lot numbers NDX550110 through NDX550843.

Users should contact Illumina, Inc. to determine if their analyzer is among the affected units and to arrange inspection and corrective action. Additional information is available from the FDA using recall number Z-0854-2022.

The recalled product

Product
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Manufacturer
Illumina, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
674

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 31 states:

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