NextSeq 550Dx Sequencing System 20005715Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816270020125), received between Nov 23, 2021 and Jun 6, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 reports).

4 FDA recall records name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 28, 2025Open, Classified

   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.

   Z-0884-2026 · Root cause: Vendor change control · FDA record ↗

2. Apr 5, 2023Completed

   Cybersecurity vulnerability concerning the software used for sequencing instruments.

   Z-1976-2023 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

3. May 3, 2022Completed

   cybersecurity vulnerability

   Z-1260-2022 · Root cause: Software in the Use Environment · FDA record ↗

4. Feb 22, 2022Completed

   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.

   Z-0854-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  THE IMPACTED PRODUCT IS THE NEXTSEQ 550 SEQUENCING SYSTEM AND SERIAL NUMBER, WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS SIMILAR TO THE NEXTSEQ¿ 550DX INSTRUMENT IN VITRO DIAGNOSTIC (IVD). THE SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY FOR THE RUO INSTRUMET IS SIMILAR TO THE IVD INSTRUMENT, THEREFORE, THIS EVENT IS BEING REPORTED AS AN MDR. NOTE: INDIVIDUAL FORMULATIONS MAY DIFFER SOMEWHAT. THE NEXTSEQ¿ 550DX INSTRUMENT IS INTENDED FOR SEQUENCING DNA LIBRARIES WITH IN VITRO DIAGNOSTIC ASSAYS. FOR ITS INPUT, THE NEXTSEQ¿ 550DX USES LIBRARIES GENERATED FROM DNA WHERE SAMPLE INDEXES AND CAPTURE SEQUENCES ARE ADDED TO AMPLIFIED TARGETS. SAMPLE LIBRARIES ARE CAPTURED ON A FLOW CELL AND SEQUENCED ON THE INSTRUMENT USING SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY. SBS CHEMISTRY USES A REVERSIBLE-TERMINATOR METHOD TO DETECT FLUORESCENTLY LABELED SINGLE NUCLEOTIDE BASES AS THEY ARE INCORPORATED INTO GROWING DNA STRANDS. ON (B)(6) 2023, A CUSTOMER REPORTED THAT THEY OBSERVED A LEAK COMING FROM THEIR NEXTSEQ 550. THE LEAK WAS DISCOVERED ABOUT 75% OF THE WAY THROUGH THE RUN. THE RUN PROCEEDED FOR ABOUT 10 HOURS BEFORE THE LEAK WAS DISCOVERED. IT APPEARS THE WASTE DISPOSAL SPOUT INSID

  Patient problems: Chemical Exposure

  MAUDE report 17075873 ↗
• MalfunctionJun 15, 2022Defective Component; Defective Component

  THE IMPACTED PRODUCT IS THE NEXTSEQ 500 SEQUENCING SYSTEM AND SERIAL NUMBER (B)(4), WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS SIMILAR TO THE NEXTSEQ 550DX INSTRUMENT IN VITRO DIAGNOSTIC (IVD). THE SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY FOR THE RUO INSTRUMENT IS SIMILAR TO THE IVD INSTRUMENT, THEREFORE, THIS EVENT IS BEING REPORTED AS AN MDR. NOTE: INDIVIDUAL FORMULATIONS MAY DIFFER SOMEWHAT. THE NEXTSEQ¿ 550DX INSTRUMENT IS INTENDED FOR SEQUENCING DNA LIBRARIES WITH IN VITRO DIAGNOSTIC ASSAYS. FOR ITS INPUT, THE NEXTSEQ¿ 550DX USES LIBRARIES GENERATED FROM DNA WHERE SAMPLE INDEXES AND CAPTURE SEQUENCES ARE ADDED TO AMPLIFIED TARGETS. SAMPLE LIBRARIES ARE CAPTURED ON A FLOW CELL AND SEQUENCED ON THE INSTRUMENT USING SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY. SBS CHEMISTRY USES A REVERSIBLE-TERMINATOR METHOD TO DETECT FLUORESCENTLY LABELED SINGLE NUCLEOTIDE BASES AS THEY ARE INCORPORATED INTO GROWING DNA STRANDS. ON (B)(6) 2022, A CUSTOMER REPORTED THAT AFTER THE RUN WAS COMPLETED ON THEIR NEXTSEQ 500, THE WASTE HAD LEAKED AS THE WASTE BOTTLE WAS NOT PLACED CORRECTLY DURING THE RUN. NO HARM OR INJURY WAS REPORTED, BUT THE CUSTOMER REPORTED BEING CONCERNED ABOUT SLIPP

  Patient problems: Chemical Exposure

  MAUDE report 14691958 ↗
• InjuryNov 23, 2021Defective Component; Defective Component

  THE IMPACTED PRODUCT IS THE NEXTSEQ 550 SEQUENCING SYSTEM (15067451) AND SERIAL NUMBER (B)(4), WHICH IS A RESEARCH USE ONLY (RUO) PRODUCT. THIS PRODUCT IS SIMILAR TO THE NEXTSEQ¿ 550DX INSTRUMENT IN VITRO DIAGNOSTIC (IVD). THE NEXTSEQ¿ 550DX INSTRUMENT IS INTENDED FOR SEQUENCING DNA LIBRARIES WITH IN VITRO DIAGNOSTIC ASSAYS. FOR ITS INPUT, THE NEXTSEQ¿ 550DX USES LIBRARIES GENERATED FROM DNA WHERE SAMPLE INDEXES AND CAPTURE SEQUENCES ARE ADDED TO AMPLIFIED TARGETS. SAMPLE LIBRARIES ARE CAPTURED ON A FLOW CELL AND SEQUENCED ON THE INSTRUMENT USING SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY. SBS CHEMISTRY USES A REVERSIBLE-TERMINATOR METHOD TO DETECT FLUORESCENTLY LABELED SINGLE NUCLEOTIDE BASES AS THEY ARE INCORPORATED INTO GROWING DNA STRANDS. THE SEQUENCING BY SYNTHESIS (SBS) CHEMISTRY FOR THE RUO INSTRUMENT IS SIMILAR TO THE IVD INSTRUMENT, THEREFORE, THIS EVENT IS BEING REPORTED AS AN MDR. NOTE: INDIVIDUAL FORMULATIONS MAY DIFFER SOMEWHAT. ON (B)(6) 2021, A CUSTOMER, (B)(6), REPORTED THAT AFTER COMPLETION OF THE SEQUENCING RUN ON ILLUMINA NEXTSEQ 550 INSTRUMENT (RUO), A PURPLE SOLUTION WAS FOUND ON THE FLOOR. THE LABORATORY WAS EVACUATED. THE SAFETY TEAM WAS ON SITE AND CLEANED THE

  Patient problems: Chest Pain; Sore Throat

  MAUDE report 12865857 ↗