Automated Hematology Analyzer XS series XS-1000i 05342311Recalls & reported problems
Sysmex Corporation · Sysmex XS-1000i™ Automated Hematology Analyzer · 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 04987562406807), received between May 10, 2018 and May 10, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Low Test Results” (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 Test Results1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2018Low Test Results; Low Test Results
ON (B)(6) 2018, THE ANALYZER GENERATED A FALSELY DECREASED HEMOGLOBIN (HGB) RESULT. ON (B)(6) 2018, THE CLINICIAN PERFORMED A COLONOSCOPY PROCEDURE ON THE PATIENT BASED ON THE LOW HGB RESULT. ON (B)(6) 2018, A SAMPLE WAS RECOLLECTED AND ANALYZED, WHICH GENERATED A HGB VALUE THAT WAS WITHIN NORMAL RANGE. ON (B)(6) 2018, REPEAT ANALYSIS OF THE ORIGINAL SAMPLE RESULTED IN A HGB VALUE THAT WAS WITHIN NORMAL RANGE. NO NEGATIVE PATIENT IMPACT WAS REPORTED DUE TO THE COLONOSCOPY PROCEDURE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS HEALTHY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7504669 ↗
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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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