COULTER LH 500 (REF 178834)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15099590265038), received between Aug 2, 2018 and Jul 7, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

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.

• MalfunctionJul 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT PATIENT SAMPLES RECOVERED ERRATIC RESULTS FOR ALL PARAMETERS ON THEIR LH500 HEMATOLOGY INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12130101 ↗
• MalfunctionJun 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INTERMITTENT HIGH PLATELET (PLT) RESULTS ON STARTUP, CONTROLS, AND PATIENT SAMPLES WHEN CYCLED ON THEIR COULTER LH 500 HEMATOLOGY ANALYZER. PATIENT DATA WAS REQUESTED BUT NOT PROVIDED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WERE NO ERRONEOUS PLATELET RESULTS RELEASED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT DUE TO THIS EVENT. INFORMATION ON WHETHER THE HIGH PLT RESULTS WERE FLAGGED WAS REQUESTED BUT COULD NOT BE CONFIRMED. THE FSE DID NOT KNOW IF THE RESULTS IN QUESTION WERE FLAGGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742106 ↗
• MalfunctionAug 2, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 500 HEMATOLOGY ANALYZER WAS GENERATING ERRONEOUSLY HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THE CUSTOMER HAS NOT REPORTED ANY CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULTS OF THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7745077 ↗