Automated Hematology Analyzer XN-L series XN-430 CL032175Recalls & reported problems
Sysmex Corporation · Automated Hematology Analyzer XN-L series XN-430 · 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 04987562434541), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Low Readings” (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
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2022Low Readings; Low Readings
THE USER ALLEGED THE SAMPLE GENERATED A FALSE LOW PLATELET (PLT) RESULT, LEADING TO UNNECESSARY STEROID TREATMENT (DEXAMETHASONE). A POST TREATMENT SAMPLE WAS ANALYZED, GENERATING A FALSE LOW PLT RESULT. A MANUAL SMEAR WAS PREPARED OF THIS SAMPLE, REVEALING THE PRESENCE OF PLT CLUMPS. THERE WAS NO KNOWN NEGATIVE IMPACT FROM THE ADMINISTRATION OF THE STEROID TREATMENT FOR THE INVOLVED PATIENT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15787837 ↗
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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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