Automated Hematology Analyzer XN series XN-20 AE797961Recalls & reported problems
Sysmex Corporation · Automated Hematology Analyzer XN series XN-20 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987562424221), received between Oct 27, 2017 and Dec 21, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Fluid/Blood Leak2
- Low Test Results2
- Charred1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2023Low Test Results; Low Test Results
IN THE UNITED KINGDOM, A PATIENT RECEIVED AN UNNECESSARY DOSE OF FILGRASTIM DUE TO A LOW WHITE BLOOD CELL (WBC) RESULT GENERATED BY XN-20 SN 15325. NO HARM TO THE PATIENT WAS REPORTED AS A RESULT OF THE UNNECESSARY TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18372160 ↗InjuryFeb 10, 2022Low Test Results; Adverse Event Without Identified Device or Use Problem; Low Test Results; Adverse Event Without Identified Device or Use Problem
A PATIENT IN (B)(6) RECEIVED AN UNNECESSARY PLATELET (PLT) TRANSFUSION BASED ON ERRONEOUS LOW PLT RESULTS GENERATED BY THE ANALYZER. THERE WAS NO HARM REPORTED DUE TO THE UNNECESSARY TRANSFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13506724 ↗InjuryFeb 18, 2021Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings
A PATIENT IN (B)(6) UNDERWENT AN UNNECESSARY ENDOSCOPY PROCEDURE BASED ON AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT GENERATED BY THE ANALYZER. THERE WAS NO HARM REPORTED DUE TO THE UNNECESSARY ENDOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11345421 ↗MalfunctionJun 28, 2018Thermal Decomposition of Device; Charred; Fluid/Blood Leak; Thermal Decomposition of Device; Charred; Fluid/Blood Leak
A USER IN (B)(6) REPORTED A BURNING ODOR COMING FROM INSIDE THE ANALYZER. A FIELD SERVICE ENGINEER (FSE) ARRIVED ON-SITE AND DISCOVERED LEAKAGE FROM A BROKEN NIPPLE ON MASTER VALVE 84 WHICH IS LOCATED IN THE VALVE ASSEMBLY 22. THE TUBING CONNECTED TO THE BROKEN NIPPLE CAUSED LEAKING ONTO VALVE ASSEMBLY 19. THE FLUID FROM THE LEAKAGE HAD DRIED OVER TIME, LEAVING SALT RESIDUE IN THE AREA. ON VALVE ASSEMBLY 19, THE FSE ALSO DISCOVERED THE PROTECTIVE PLASTIC SHEET AND WIRES WERE MELTED AND CHARRED. NO HARM OR INJURY TO OPERATOR WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7647958 ↗InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SAMPLE WAS COLLECTED USING A SYRINGE AND FINE GAUGE NEEDLE. ANALYSIS WAS PERFORMED ON (B)(6) 2017, TIME UNKNOWN, AND THE USER STATED THAT A PLT VALUE OF 70 X 10^9/L WAS REPORTED TO THE CLINICIAN. A BONE MARROW ASPIRATION PROCEDURE WAS PERFORMED. THE REASON FOR THE PROCEDURE WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT BLED MORE THAN NORMAL DURING THE PROCEDURE. THE CLINICIAN REQUESTED A REPEAT ANALYSIS, WHICH GENERATED A PLT VALUE OF 5 X 10^9/L. NO OTHER PATIENT INFORMATION WAS PROVIDED.
Patient problems: Blood Loss
MAUDE report 6985602 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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