COULTER LH 500 (REF 178833)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15099590265045), received between Oct 7, 2016 and Jul 27, 2018 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED INTERMITTENT ERRATIC HIGH PLATELET RESULTS ON THEIR COULTER LH 500 HEMATOLOGY ANALYZER. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7727042 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE COULTER LH 500 HEMATOLOGY ANALYZER GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. INSTRUMENT PRINTOUTS OF PATIENT RESULTS OR CONTROLS WERE NOT PROVIDED FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7726900 ↗
• MalfunctionJul 3, 2018Improper Device Output; Improper Device Output

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 500 HEMATOLOGY ANALYZER GENERATED INTERMITTENT ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT. INSTRUMENT PRINTOUTS OF PATIENT RESULTS WERE NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7660393 ↗
• MalfunctionNov 15, 2017Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR LH500 INSTRUMENT WAS HAVING REPRODUCIBILITY ISSUES. THE CUSTOMER ALSO REPORTED THAT ONE LEVEL OF CONTROL DID NOT COME IN WITHIN RANGE BUT INSTRUMENT WAS STILL USED TO PROCESS PATIENT SAMPLES. THE CUSTOMER HAD TWO PATIENT SAMPLES THAT WERE RERUN AND RESULTED IN DIFFERENT RESULTS FROM THE ORIGINAL RUN. THE CUSTOMER ALSO STATED THAT THE SAME INSTRUMENT WAS GENERATING A LARGE NUMBER (5 OUT OF 22 SAMPLES) OF VOTEOUTS FOR RBC AND MVC RESULTS. OUT OF THE TWO SAMPLES THAT WERE REPORTED AS ERRONEOUS ONE HAD FLAGGED RESULTS PROMPTING THE OPERATOR TO REVIEW THE RESULTS. THE SECOND PATIENT RESULT DID NOT GENERATE ANY FLAGS WITH THE RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT.

  Patient problems: Test Result

  MAUDE report 7035671 ↗
• MalfunctionNov 2, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED AN UNCONTAINED LEAK FROM THE COULTER LH 500 HEMATOLOGY ANALYZER WHILE PERFORMING SHUTDOWN. THE VOLUME OF THE LEAK WAS APPROXIMATELY 2ML. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, GOGGLES AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6073807 ↗
• MalfunctionOct 28, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED APPROXIMATELY 20 ML OF CLENZ LEAKED FROM A COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS.

  Patient problems: Not Applicable

  MAUDE report 6064700 ↗
• MalfunctionOct 25, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED APPROXIMATELY 20 CC OF CLEAR FLUID LEAKED FROM A COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS.

  Patient problems: Not Applicable

  MAUDE report 6054794 ↗
• MalfunctionOct 24, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED APPROXIMATELY 10 ML OF CLEAR FLUID LEAK FROM A COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, FACE SHIELD AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS OR CONTROLS.

  Patient problems: Not Applicable

  MAUDE report 6051380 ↗
• MalfunctionOct 7, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED AN UNCONTAINED LEAK OF APPROXIMATELY 25ML OF CLEAR FLUID FROM A COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING GLOVES AND A LABORATORY COAT WHEN THE LEAK WAS DISCOVERED. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE EVENT.

  Patient problems: Not Applicable

  MAUDE report 6012324 ↗