COULTER LHRecalls & reported problems across all models

We found 4 models of COULTER LH by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2016 and Aug 15, 2022 — classified as 2 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Output Problem” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported COULTER LH problems

COULTER LH models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• COULTER LH 780

  Counter, Differential Cell
  20 reports
• COULTER LH 750

  Counter, Differential Cell
  15 reports
• COULTER LH 500

  Counter, Differential Cell
  9 reports
• COULTER LH 500

  Counter, Differential Cell
  3 reports

Recent COULTER LH adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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