Automated Hematology Analyzer XN-L series XN-550 BD634545Recalls & reported problems
Sysmex Corporation · Automated Hematology Analyzer XN-L series XN-550 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987562434572), received between Feb 14, 2019 and Feb 14, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2019Use of Device Problem; Use of Device Problem
THE PATIENT'S SAMPLE WAS ANALYZED AND THE ANALYZER GENERATED "INSUFFICIENT BLOOD VOLUME (SHORT SAMPLE)" ERRORS. RESULTS WERE DISPLAYED AS DASHES (---), INDICATING ENUMERATION WAS NOT POSSIBLE. THE SAMPLE WAS REPEATED TWO MORE TIMES WITH THE SAME RESULTS. THE USER PERFORMED THE RBC DETECTOR CLOG THREE TIMES AND NO CLOT WAS OBSERVED. THE USER THEN CHECKED THE SAMPLE FOR CLOTS, HOWEVER NONE WERE DETECTED. THE PATIENT WAS RECOLLECTED TO FURTHER RULE OUT A CLOTTED SPECIMEN. THE RECOLLECTED SAMPLE ANALYSIS GENERATED THE SAME ERROR. THE USER PERFORMED A CLEANING PROCEDURE AND REPEATED THE SAMPLE, HOWEVER THE ERROR PERSISTED. THE USER THEN SENT THE SAMPLE TUBE TO A REFERENCE LAB. THE REFERENCE LAB RESULTS INDICATED A HEMOGLOBIN (HGB) OF 3.2 G/DL. A CROSSMATCH FOR ONE PACKED RBC WAS ORDERED AND TRANSFUSED. THE USER ATTEMPTED TO TROUBLESHOOT BY DISABLING THE ASPIRATION SENSOR IN THE ANALYZER SETTINGS AND THEN REPEATED THE ORIGINAL SAMPLE. THE ANALYZER GENERATED A HGB OF 3.2 G/DL, WHICH MATCHED THE RESULT FROM THE REFERENCE LAB. THE USER ALLEGED THE RBC TRANSFUSION WAS DELAYED 2 HOURS DUE TO THE ANALYZER NOT GENERATING NUMERICAL VALUES. NO HARM TO THE PATIENT WAS REPORTED BASED ON THIS DELAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8341678 ↗
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- CELL-DYN 08H00-01Abbott Laboratories · Counter, differential cell1 recall90 reports
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- BD Multitest 662995Becton, Dickinson And Company · Counter, differential cell2 recalls1 report
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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