COULTER LH 780Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 15099590282431), received between Oct 12, 2016 and Dec 22, 2021 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Output Problem” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2021Fire; Electrical Shorting; Fire; Electrical Shorting

  THE CUSTOMER REPORTED WHILE TURNING ON THE MAIN SWITCH FOR THE COMPRESSOR FOLLOWING A POWER SURGE FROM A THUNDERSTORM; A BURST INSIDE THE COMPRESSOR WAS HEARD WITH A SMALL FLAME AND SMOKE WERE SEEN COMING FROM THE SOUND ABSORBING PADDING OF THE COMPRESSOR IN THE LH780 HEMATOLOGY INSTRUMENT. THE POWER SUPPLY WAS IMMEDIATELY DISCONNECTED. THE CUSTOMER THEN DOUSED INSTRUMENT WITH WATER. A FIRE EXTINGUISHER WAS NOT USED. THE FIRE WAS CONTAINED WITHIN THE INSTRUMENT. THE FIRE DEPARTMENT WAS NOT CALLED NO MEDICAL ATTENTION NEEDED, THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT OR CUSTOMER DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13067443 ↗
• MalfunctionAug 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE PLATELET (PLT) PARAMETER RECOVERED HIGH FOR APPROXIMATELY SIX PATIENT SAMPLES WITHOUT SUSPECT MESSAGING WHEN CYCLED ON THEIR COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER ALSO REPORTED AIR BUBBLES IN THE WBC DISPENSER DURING THE EVENT. PER DOCUMENTATION, NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. QUESTIONED SAMPLES WITH HIGH PLATELETS WERE RERUN AND REPORTED FROM A DIFFERENT ANALYZER. CONTROLS RECOVERED WITHIN SPECIFICATION BEFORE AND AFTER THE EVENT. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS INCIDENT, NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT. ONLY ONE PRINTOUT FOR ONE PATIENT RESULT WAS PROVIDED BY THE CUSTOMER, THE OTHER FIVE COULD NOT BE CONFIRMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10418363 ↗
• MalfunctionJun 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR LH780 ANALYTICAL STATION HAS GENERATED ERRATIC HIGH PLATELET (PLT) RESULTS. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. THERE WAS NO CHANGE IN PATIENT TREATMENT, OR DEATH OR INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719932 ↗
• InjuryMar 22, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THE CUSTOMER REPORTED THAT A WASTE HOSE BECAME DISLODGED AND WASTE FLUIDS CAME IN CONTACT WITH THE OPERATOR WHILE USING THEIR LH780 ANALYTICAL STATION. THE CUSTOMER STATED THAT A HOSE THAT CARRIED BIOLOGICAL WASTE FROM THE INSTRUMENT TO THE WASTE CONTAINER BECAME DISLODGED DURING SAMPLE PROCESSING. A SPILL OCCURRED THAT CAME IN CONTACT WITH THE OPERATOR'S SKIN AND EYES. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES WITH NO FACE PROTECTION. THE OPERATOR WAS SEEN BY A DOCTOR AND WAS FOUND TO BE IN GOOD HEALTH BUT WAS PRESCRIBED RETROVIRAL MEDICATION AS A PREVENTIVE MEASURE. NO FURTHER TREATMENT REQUIREMENT WAS REPORTED. THERE WERE NO ERRONEOUS RESULTS GENERATED AS A RESULT OF THIS EVENT. THERE WAS NO EFFECT TO PATIENT TREATMENT. THE INSTRUMENT WAS INSTALLED ON (B)(6) 2018, THE EVENT OCCURRED IN (B)(6) 2019 DURING ITS FIRST USE.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8445070 ↗
• MalfunctionOct 25, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 780 HEMATOLOGY ANALYZER WAS DILUTING PATIENT SAMPLES AND GENERATING ERRONEOUS RESULTS. THE CUSTOMER HAD OBSERVED THERE WAS FLUID ON TOP OF THE FLUID CAPS AFTER PIERCING AND THAT SAMPLE RESULTS WERE ERRATIC. 36 PATIENT REPORTS OF THE INITIAL SAMPLE RESULTS WERE PROVIDED. THE QC CONTROLS HAD RUN AS EXPECTED. THE CUSTOMER INDICATED THAT THEY RERAN THE SAMPLES BUT CONSIDERED THEM TO BE ALREADY DILUTED AND DID NOT SEND THE REPORTS. THEY LEFT THE DECISION FOR PATIENT REDRAWS AT THE DISCRETION OF THE MEDICAL PRACTITIONER. THE CUSTOMER, UPON REVIEWING THE RESULTS FOR THE REDRAW OF PATIENT ID (B)(6), FOUND THAT THE PLATELET RESULTS HAD A LOWER VALUE THAN THE ORIGINAL RUN.

  Patient problems: Test Result

  MAUDE report 8005297 ↗
• MalfunctionSep 11, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR LH780 HEMATOLOGY ANALYZER GENERATED PLT VOTEOUTS AND ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF IMPACT OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE THE PATIENT DATA FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7866776 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED INTERMITTENT HIGH RED BLOOD CELLS (RBC) AND PLATELET (PLT) RESULTS FROM A COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE SAMPLES WERE RE-RUN ON A BACKUP INSTRUMENT. THE CUSTOMER DID NOT REPORT ERRONEOUS PATIENT RESULTS OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT.

  Patient problems: Test Result

  MAUDE report 7729043 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED INTERMITTENT HIGH RED BLOOD CELLS (RBC) AND PLATELET (PLT) RESULTS FROM A COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THE REPEAT RUNS DID NOT CORRELATE. THE CUSTOMER DID NOT REPORT PATIENT RESULTS OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT.

  Patient problems: Test Result

  MAUDE report 7726990 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEY ARE GETTING HIGH PLATELET (PLT) COUNTS FOR BOTH PATIENT SAMPLES AND CONTROLS ON THEIR COULTER LH 780 HEMATOLOGY ANALYZER. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. 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 7726922 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 780 HEMATOLOGY ANALYZER WAS GENERATING ERRONEOUS LOW HEMOGLOBIN (HGB) AND HIGH PLATELET (PLT) RESULTS. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. 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 7726916 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 780 HEMATOLOGY ANALYZER IS GENERATING HIGH PLATELET (PLT) RESULTS. 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 7726898 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE RBC (RED BLOOD CELL) AND PLT (PLATELET) RESULTS GENERATED ON THEIR COULTER LH 780 HEMATOLOGY ANALYZER ARE ERRATIC. THE RESULTS WERE DESCRIBED TO HAVE VARIED FROM ZERO TO VERY HIGH. 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 7726876 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER LH 780 HEMATOLOGY ANALYZER WAS GENERATING ERRATIC PLATELET (PLT) RESULTS AND THE CONTROLS WERE ALSO BIASED HIGH FOR PLATELETS. THE CUSTOMER HAD NOT REPORTED ANY ERRONEOUS RESULTS OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. THE ISSUE WAS REPORTED AS AN ONGOING ISSUE FOR A TWO WEEK PERIOD BY THE CUSTOMER BUT THEY HAD NOT CALLED TO REPORT IT PREVIOUS TO THIS CALL.

  Patient problems: Test Result

  MAUDE report 7726875 ↗
• MalfunctionJul 21, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED HAVING LOW MCHC FOR PATIENT SAMPLES ON THEIR COULTER LH 780 HEMATOLOGY ANALYZER. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7708950 ↗
• MalfunctionDec 1, 2016Output above Specifications; Output above Specifications

  THE CUSTOMER REPORTED THAT THE LH780 ANALYZER GENERATED ERRONEOUS HIGH BASOPHIL (BA) COUNTS FOR PATIENT SAMPLES. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

  Patient problems: Not Applicable

  MAUDE report 6138926 ↗
• MalfunctionNov 3, 2016Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  THE CUSTOMER REPORTED AN UNCONTAINED STAIN LEAK OF APPROXIMATELY 10 ML IN VOLUME FROM THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND A LAB COAT AT THE TIME OF THE EVENT. 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 TO THE EVENT.

  Patient problems: Not Applicable

  MAUDE report 6075581 ↗
• MalfunctionNov 2, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED AN UNCONTAINED LEAK OF 50ML FROM THE COULTER LH 780 HEMATOLOGY ANALYZER WHILE RUNNING THE ANALYZER. THERE WERE LOW VAC DRIFTED ERROR MESSAGES REPORTED BY THE CUSTOMER AT THE TIME OF THE EVENT. 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, PROTECTIVE EYEWEAR 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 6074813 ↗
• MalfunctionOct 27, 2016Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED A LEAK OF BLOOD-DILUENT AND CBC LYSE FLUID OF APPROXIMATELY < 1.0 ML IN VOLUME WHICH WAS CONTAINED WITHIN THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT. 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 TO THE EVENT.

  Patient problems: Not Applicable

  MAUDE report 6061786 ↗
• MalfunctionOct 26, 2016Output Problem; Output Problem

  THE CUSTOMER REPORTED THE THEIR COULTER LH 780 HEMATOLOGY ANALYZER WAS EXPERIENCING WBC APERTURE 3 VOTEOUTS. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6059175 ↗
• MalfunctionOct 12, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED A LEAK DESCRIBED AS 30 ML OF BLOOD AND DILUENT FROM A COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, LABORATORY GOWN AND GOGGLES AT THE TIME OF THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT.

  Patient problems: Not Applicable

  MAUDE report 6024746 ↗