DxH 500 B40601Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15099590671242), received between May 23, 2019 and May 20, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT PATIENT SAMPLES ARE RECOVERING WITH ERRONEOUS HIGH PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH500 HEMATOLOGY INSTRUMENT. NO REPORT OF ERRONEOUS RESULTS SENT OUT OF THE LABORATORY. THERE WERE NO ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF ANY INJURIES, DEATHS, OR DELAYS/CHANGES IN TREATMENT OR DIAGNOSIS TO PATIENT OR USER. PATIENT DATA WAS NOT PROVIDED FOR REVIEW. ON SITE SERVICE WAS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056794 ↗
• InjuryJul 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEIR DXH 500 HEMATOLOGY INSTRUMENT GENERATED AN ERRONEOUSLY HIGH PLATELET (PLT) RESULT FOR ONE PATIENT SAMPLE. THE PATIENT DISCONTINUED MEDICATION FOR THEIR THROMBOCYTOPENIA CAUSING DISEASE PROGRESSION. THE PATIENT ARRIVED TO THE CLINIC ON 16-APRIL-2024, FOR TREATMENT OF THROMBOCYTOPENIA. WHEN TESTED, THE PATIENT SAMPLE REFLECTED NORMAL PLATELET PARAMETER RESULT. HOWEVER, THREE DAYS AFTER THE PATIENT STOPPED TAKING MEDICATION, THEY BEGAN TO SUFFER FROM GUM BLEEDING. THE PATIENT WENT TO A DIFFERENT HOSPITAL, A SAMPLE WAS DRAWN AND TESTED AND THE PLT RESULT WAS SIGNIFICANTLY LOWER. ON 22-APRIL-2024, THE PATIENT CAME TO THE INITIAL HOSPITAL TO COMPLAIN THAT THE HOSPITAL'S EXAMINATION RESULTS WERE INACCURATE AND HAD MISLED HER TO STOP TAKING MEDICATION, RESULTING IN UNCONTROLLED DISEASE PROGRESSION. AFTER RECEIVING THE COMPLAINT, THE LABORATORY DEPARTMENT FOUND THE SPECIMEN THAT WAS EXAMINED ON APRIL 16 AND RE-EXAMINED IT ON APRIL 22, 6 DAYS AFTER ORIGINAL SAMPLE COLLECTION (PER INSTRUCTIONS FOR USE DXH 500, PART C42118AA, THIS IS AN INADEQUATE SAMPLE). IT WAS FOUND THAT THE PLATELET COUNT WAS SIGNIFICANTLY LOWER COMPARED TO THE INITIAL RESULT. THE INVESTIGA

  Patient problems: Thrombocytopenia

  MAUDE report 19792950 ↗
• MalfunctionAug 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT REPEATABILITY FAILED FOR THE PLATELET (PLT) PARAMETER ON THE DXH500 HEMATOLOGY INSTRUMENT. CUSTOMER REPORTED THAT THERE WERE LESS THAN FIVE PATIENT SAMPLE RESULTS IMPACTED. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WAS NO INDICATION OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258410 ↗
• MalfunctionNov 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING HIGH PLATELET (PLT) VALUES FOR PATIENT SAMPLES POST PREVENTATIVE MAINTENANCE (PM) WHEN RUN ON THEIR DXH500 HEMATOLOGY INSTRUMENT. THERE WAS NO REPORT OF AN ADVERSE EVENT. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. PATIENT DATA WAS REQUESTED BUT NOT PROVIDED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888750 ↗
• MalfunctionJul 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCORRECT PLATELET (PLT) VALUES ON ONE PATIENT SAMPLE THAT WAS RUN ON THEIR DXH 500 HEMATOLOGY INSTRUMENT. THERE WAS NO REPORT OF CHANGE OR EFFECT ON PATIENT TREATMENT. THE CUSTOMER SENT THESE SAMPLES TO THE REFERENCE LAB AND CONFIRMED THE PLT VALUES WERE HIGHER ON THE DXH500. A MANUAL SMEAR WAS PERFORMED AND THE RESULT CORRELATED WITH THE LOWER VALUES WERE CONSIDERED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200542 ↗
• MalfunctionApr 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED HIGHER PLATELET (PLT) VALUES THAN EXPECTED ON PATIENT SAMPLES THAT WERE RUN ON THEIR DXH 500 HEMATOLOGY INSTRUMENT. THE SAMPLES IN QUESTION WERE SENT TO REFERENCE LAB AND CONFIRMED TO BE ERRONEOUSLY HIGHER ON THE DXH 500. THERE WAS NO REPORT OF CHANGE OR EFFECT ON PATIENT TREATMENT. THE CUSTOMER INDICATED THAT CONTROLS WERE FAILING TO RECOVER WITHIN THE EXPECTED RANGES (HIGH PLT), AND ATTEMPTED SEVERAL TIMES IN ORDER FOR THE CONTROLS TO PASS. ONCE THE CONTROLS PASSED, THE CUSTOMER BEGAN USING THE INSTRUMENT TO PROCESS PATIENT SAMPLES. THE CUSTOMER REPORTED THAT THERE WERE A NUMBER PATIENT SAMPLES THAT HAD HIGHER RESULTS FOR PLATELETS THAN EXPECTED. THE CUSTOMER SENT THESE SAMPLES TO THE REFERENCE LAB AND CONFIRMED THE PLT VALUES WERE HIGHER ON THE DXH500 AND THE LOWER VALUES WERE CONSIDERED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737832 ↗
• MalfunctionApr 21, 2021Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR DXH 500 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUSLY HIGH PLATELET (PLT) RESULTS ON ONE PATIENT WITH NO FLAGGING OR ALERT ON PLT CLUMPS THE PATIENT SAMPLE WAS INITIALLY RUN ON A DXH 800 HEMATOLOGY INSTRUMENT WHICH GENERATED R FLAGS AND A PLT RESULT OF 14.0 AND PROMPTED THE OPERATOR TO REVIEW THE RESULTS. THEY RERAN THE PATIENT ON THE DXH 500 GENERATING MUCH HIGHER PLT RESULTS (125.4) PROMPTING FOR A MANUAL SLIDE REVIEW THAT COINCIDED WITH THE INITIAL RUN ON THE DXH 800 AND CONFIRMED PLT CLUMPS ON THE SAMPLE. THERE WAS NO INDICATION OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY RAW DATA FROM THE INSTRUMENT WAS REQUESTED BUT NOT PROVIDED. PATIENT RESULTS WERE PROVIDED AND ASSESSED FOR THIS EVENT. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULTS OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700487 ↗
• MalfunctionJan 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT WBC,RBC,HGB (HEMOGLOBIN) AND PLT (PLATELET) PATIENT RESULTS WERE RECOVERED ON THE DXH 500 INSTRUMENT WHEN COMPARED TO THE RESULTS RECOVERED ON THEIR DXH 600 INSTRUMENT, WHICH WERE CONSIDERED CORRECT. PATIENT DATA WAS PROVIDED IN AN EXCEL SPREADSHEET. INSTRUMENT PRINTOUTS WERE REQUESTED BUT WERE NOT PROVIDED BY THE CUSTOMER. INSTRUMENT FLAGGING OF RESULTS COULD NOT BE DETERMINED. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF THE LAB. 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 11207745 ↗
• MalfunctionJan 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SAMPLE RESULTS OF ONE PATIENT WERE REPORTED OUT OF THE LAB AS ANOTHER PATIENT'S RESULTS, THE EVENT OCCURRED ON A DXH500 AT A CUSTOMER SITE IN (B)(6). THE OPERATOR SCANNED A SAMPLE AND THE DEMOGRAPHICS ON THE PRINTOUT WERE OF ANOTHER PATIENT FOUND ON THE WORK LIST THAT WAS GENERATED AUTOMATICALLY BY THE LIS. THERE WAS NO DEATH OR INJURY REPORTED AS A RESULT OF THIS EVENT. IMPACT TO PATIENT TREATMENT WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9645078 ↗
• MalfunctionMay 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR DXH 500 HEMATOLOGY INSTRUMENT WAS GENERATING ERRONEOUS HIGH PLATELET RESULTS FOR A SINGLE PATIENT THAT WERE DEEMED INCONSISTENT WITH THE CLINICAL HISTORY OF THE PATIENT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER. PER ADDITIONAL INFORMATION PROVIDED BY THE INITIAL REPORTER ON (B)(6) 2019, THE PLATELET RESULTS WERE CONSIDERED HIGHER THAN THE EXPECTED VALUES FOR THIS PATIENT AND THEY WERE CONSIDERED ERRONEOUS BASED ON THE COUNTS PROVIDED. THE INSTRUMENT DID NOT TRIGGER ANY FLAGS OR MESSAGES FOR THE SAMPLE CONSIDERED ERRONEOUS THE CUSTOMER CALLED THE BEC HOTLINE AND STATED THEY HAD AN INCONSISTENCY WITH THE RESULTS OF A PATIENT AND REQUESTED GUIDANCE THROUGH PERFORMING THE BLEACH CYCLE PROCEDURE FOR THE INSTRUMENT. THE CUSTOMER HAD WRITTEN IN THEIR NOTES THAT BLEACHING HAD TO BE DONE EVERY 2 MONTHS AND HAD NOT BEEN DONE. THE CUSTOMER DID NOT PROCESS ANY MORE SAMPLES UNTIL THEY PERFORMED THE BLEACHING OF THE INSTRUMENT.

  Patient problems: Test Result

  MAUDE report 8638859 ↗