COULTER LH 750Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 15099590264772), received between Oct 13, 2016 and Aug 15, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Output Problem” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUSLY HIGH PLATELET RESULTS FOR FIVE (5) PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE IDENTIFIED BEFORE BEING RELEASED OUT OF THE LABORATORY. THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT. THERE WAS NO REPORT OF AN ADVERSE EVENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15227785 ↗
• MalfunctionMar 23, 2020Output Problem; Output Problem

  CUSTOMER REPORTED ERRATIC HIGH PLATELETS ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER DID NOT SPECIFY IF THE HIGH PLATELETS OCCURED DURING CONTROLS OR PATIENT RESULTS. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT FO THIS EVENT. THE CUSTOMER INDICATED THAT, "THEY HAVE INTERNAL CHECKS FOR ELEVATED AND (OR) ABNORMAL RESULTS, WHICH INCLUDES PATIENT HISTORY, RUNNING THE SAME SAMPLE ON THE OTHER INSTRUMENT, AND (OR) MAKING A MANUAL SLIDE ETC. THEY FEEL CONFIDENT THAT THEIR INTERNAL PROCEDURES PREVENTED ANY FALSELY ELEVATED PLT RESULT FROM BEING RELEASED, AND AS FAR AS THEY KNOW, NO PATIENT WAS IMPACTED" NEITHER PRINTOUTS FOR PATIENT DATA OR QC RESULTS WERE PROVIDED BY THE CUSTOMER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866519 ↗
• MalfunctionOct 20, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 750 HEMATOLOGY ANALYZER WAS GENERATING ERRONEOUS PLATELET RESULTS. IT IS UNKNOWN WHETHER IT WAS CONTROLS OR PATIENT SAMPLES THAT WERE IMPACTED. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER. THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR AFFECT TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7988085 ↗
• MalfunctionOct 19, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 750 HEMATOLOGY ANALYZER WAS GENERATING ERRONEOUSLY HIGH PLATELET RESULTS. IT IS UNKNOWN WHETHER IT WAS CONTROLS OR PATIENT SAMPLES THAT WERE IMPACTED. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER. THERE WAS NO REPORT OF CHANGE TO PATIENT TREATMENT OR AFFECT TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7987786 ↗
• InjuryOct 15, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 750 HEMATOLOGY ANALYZER GENERATED ERRONEOUS LOW HEMOGLOBIN (HGB) RESULTS FOR PATIENTS. CUSTOMER INDICATED THAT THE INSTRUMENT WAS GENERATING ERRONEOUS ERRATIC HGB COUNT FOR THEIR PATIENT SAMPLES. ALTHOUGH IT WAS INITIALLY REPORTED THAT 9 PATIENT HAD ERRONEOUS RESULTS, ONLY ONE PATIENT WAS CONFIRMED FOR AN ERRONEOUS RESULT, AND RECEIVED A TRANSFUSION. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT. PER TELEPHONE CONVERSATION WITH THE LAB MANAGER ON (B)(6) 2018, SHE INDICATED THAT AS A STANDARD QUALITY CONTROL PRACTICE, THEY REVIEW ALL THE RESULTS THAT THEY CONSIDER SUSPICIOUS, AND ONLY A SINGLE (1) TRANSFUSION OCCURRED, AND NOT TWO (2) TRANSFUSIONS AS ORIGINALLY REPORTED. THE LAB MANAGER PUT A CALL OUT, AS SOON AS THEY BECAME AWARE THAT AN ERRONEOUS RESULT HAD BEEN RELEASED, BUT THE TRANSFUSION HAD ALREADY OCCURRED. TO THE BEST OF HER KNOWLEDGE, THE TRANSFUSION DID NOT IMPACT THE GENERAL CONDITION OF THE PATIENT, AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE TRANSFUSION. PER TELEPHONE CONVERSATION WITH THE OPERATOR ON 27-SEPT-18 AND 01-OCT-18, SHE INDICATED THAT THE SYSTEM TRIGGERED AN ALE

  Patient problems: Test Result

  MAUDE report 7965460 ↗
• MalfunctionSep 5, 2018Output Problem; Output Problem

  CUSTOMER REPORTED HAVING HIGH PLATELETS ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER DID NOT SPECIFY IF THE HIGH PLATELETS OCCURRED DURING CONTROLS OR PATIENT RESULTS. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7845007 ↗
• MalfunctionSep 5, 2018Output Problem; Output Problem

  CUSTOMER REPORTED THAT PLATELET RESULTS WERE NOT CORRECT ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER DID NOT SPECIFY IF THE PLATELET ISSUE OCCURED DURING CONTROLS OR PATIENT RESULTS OR WHETHER THEY WERE HIGH, LOW OR VOTEOUTS. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT FO THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7844999 ↗
• MalfunctionSep 5, 2018Output Problem; Output Problem

  CUSTOMER REPORTED THAT PLATELET RESULTS WERE HIGH ON THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER DID NOT SPECIFY IF THE PLATELET ISSUE OCCURED DURING CONTROLS OR PATIENT RESULTS. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT FO THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7844990 ↗
• MalfunctionNov 7, 2016Fluid/Blood Leak; Split; Fluid/Blood Leak; Split

  THE CUSTOMER REPORTED A LEAK OF UNSPECIFIED VOLUME ON A COULTER LH 750 HEMATOLOGY ANALYZER. THE INSTRUMENT HAD GENERATED DIFFERENTIAL VOTEOUTS ON CONTROLS AT THE TIME OF THE EVENT. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND WAS A MIXTURE OF DILUENT AND WHOLE BLOOD. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF 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.

  Patient problems: Not Applicable

  MAUDE report 6083420 ↗
• MalfunctionNov 1, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE PREFORMING STARTUP AN UNCONTAINED FLUID LEAK OF APPROXIMATELY 5ML WAS OBSERVED IN THEIR COULTER LH 750 HEMATOLOGY ANALYZER. 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 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 6070753 ↗
• MalfunctionOct 25, 2016Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED A LEAK FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS ABOUT 5 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT. 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 WITH THIS EVENT.

  Patient problems: Not Applicable

  MAUDE report 6054043 ↗
• MalfunctionOct 25, 2016Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED AN UNSPECIFIED VOLUME OF STABILYSE LEAKED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, GLOVES AND GLASSES 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 6053505 ↗
• MalfunctionOct 19, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED AN UNCONTAINED CLENZ LEAK OF LESS THAN 50 ML FROM A COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME THE LEAK WAS DISCOVERED, 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 WITH THE EVENT.

  Patient problems: Not Applicable

  MAUDE report 6040140 ↗
• MalfunctionOct 17, 2016Output Problem; Output Problem

  WHILE A FIELD SERVICE ENGINEER (FSE) WAS TROUBLESHOOTING AN UNRELATED EVENT, THE FSE FOUND HIGH WBC (WHITE BLOOD CELL) AND RBC (RED BLOOD CELL) CV'S (COEFFICIENT OF VARIATION) ON THE COULTER LH 750 HEMATOLOGY ANALYZER. 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 6034326 ↗
• MalfunctionOct 13, 2016Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED APPROXIMATELY 50ML OF BLOODY FLUID LEAKED UNDER THEIR COULTER LH750 HEMATOLOGY ANALYZER, NO ALARMS WERE GENERATED AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT; SERVICE WAS DISPATCHED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, LAB COAT, AND EYE PROTECTION WHEN THE LEAK WAS IDENTIFIED AND THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AND NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6028727 ↗