DxH 520 B40602Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15099590679781), received between Sep 16, 2020 and Apr 9, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE DXH 520 ANALYZER (PRODUCT NUMBER B40602, SERIAL NUMBER (B)(6) GENERATED ERRONEOUS HIGH HEMOGLOBIN (HGB) RESULTS FOR ONE PATIENT SAMPLE. ALTHOUGH THE HGB RESULT WAS 11G/DL, THE PATIENT WAS SENT TO THE HOSPITAL BASED ON PHYSICAL ASSESSMENT. A GASOMETER READING WAS CARRIED OUT AT THE HOSPITAL AND THE HGB RESULT WAS 4 POINTS LOWER THAN THE ORIGINAL HGB RESULT. THE PATIENT WAS ADMINISTERED A TRANSFUSION AT THE HOSPITAL. ADDITIONAL DETAILS REGARDING THE TRANSFUSION WERE REQUESTED BUT THE CUSTOMER DID NOT PROVIDE ANYMORE INFORMATION ON THE BASIS OF PATIENT CONFIDENTIALITY. IT IS UNKNOWN IF THE PATIENT HAS A PREEXISTING CONDITION OR WAS SENT TO THE HOSPITAL TO HAVE THE TRANSFUSION ADMINISTERED. IT WAS CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT AND NO DELAY TO PATIENT TREATMENT AS A RESULT OF THE ERRONEOUS HGB RESULT. ON SITE SERVICE WAS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24837944 ↗
• MalfunctionFeb 10, 2026Mechanical Problem

  THE CUSTOMER REPORTED ERRONEOUS PATIENT RESULTS ACCOMPANIED WITH FLAGGING (R FLAGS) GENERATED ON THEIR DXH 520 HEMATOLOGY ANALYZER (PRODUCT NUMBER: B40602, SERIAL NUMBER: (B)(6). THE SAME SAMPLE PRODUCED DIFFERENT RESULTS UPON RERUN, AND OCCASIONALLY, RESULTS WERE NOT GENERATED (DISPLAYED AS DASHES OR ZERO VALUES). THERE WAS NO REPORT OF ERRONEOUS RESULTS BEING RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY INJURIES, DEATHS, OR DELAYS/CHANGES IN TREATMENT OR DIAGNOSIS RELATED TO THE REPORTED ISSUE. PATIENT DATA WAS PROVIDED REFLECTING ERRATIC RESULTS ACCOMPANIED BY INSTRUMENT FLAGGING (R FLAGS). ONSITE SERVICE WAS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307174 ↗
• MalfunctionFeb 3, 2026Output Problem

  THE CUSTOMER REPORTED RECURRING ¿R FLAGS¿ AND ERRONEOUS RESULTS ON MULTIPLE PATIENT SAMPLES USING THE DXH 520 HEMATOLOGY INSTRUMENT (PRODUCT NUMBER B40602, SERIAL NUMBER (B)(6)). THE ISSUE REQUIRED FREQUENT SAMPLE RERUNS, WITH RESULTS NOT ALIGNING WITHIN AN ACCEPTABLE 10% MARGIN. THE PROBLEM PERSISTED ACROSS VARIOUS PARAMETERS, NOTABLY RBCS AND PLATELETS. THERE WAS NO REPORT OF DEATH, INJURY, DELAY OR CHANGE TO PATIENT TREATMENT OR DIAGNOSIS AND THERE WAS NO REPORT OF HARM TO PATIENT, OPERATOR OR ANY OTHER PERSON RELATED TO THE REPORTED ISSUE. ONSITE SERVICE WAS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254885 ↗
• MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ONE PATIENT SAMPLE RECOVERED WITH AN INCORRECT SAMPLE IDENTIFICATION NUMBER WHEN RUN ON THEIR DXH520CP HEMATOLOGY INSTRUMENT. NO INCORRECT NUMERICAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326949 ↗
• MalfunctionJan 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED EXTREMELY HIGH PLATELET (PLT) RESULTS WERE GENERATED ON THEIR DXH520CP INSTRUMENT AFTER REPLACING THE DILUENT. CUSTOMER PERFORMED A SHUTDOWN AND DAILY CHECKS PRIOR TO CONTACTING BECKMAN COULTER FOR THE EVENT. THE CUSTOMER TECHNICAL SPECIALIST (CTS) VERIFIED THE EVENT VIA TELEPHONE AND FOUND 15 PATIENT SAMPLES RECOVERED WITH ERRONEOUS HIGH PLT RESULTS (OVER 1 MILLION PLATELETS) FOLLOWING THE REPLACEMENT OF DILUENT. THE ERRONEOUS RESULTS WERE IDENTIFIED BEFORE BEING RELEASED AND DID NOT LEAVE 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 16235716 ↗
• MalfunctionJan 11, 2022Patient Data Problem; Patient Data Problem

  THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND CONFIRMED WHAT THE CUSTOMER HAD REPORTED. TO RESOLVE THE ISSUE THE FSE REPLACED THE RBC CHAMBER AND THE RBC LATEX CALIBRATOR. BEC INTERNAL IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233696 ↗
• MalfunctionOct 11, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THERE WAS ONE INSTANCE WERE BOTH THEIR DXH520 CP HEMATOLOGY INSTRUMENTS HAD THE SAME SEQUENCE NUMBER (DUPLICATE PATIENT ID) THAT RESULTED IN A CHARTING ERROR. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, HOWEVER, THERE WAS NO REPORTED CHANGE OR EFFECT ON PATIENT TREATMENT. THERE WAS NEITHER DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. THE CUSTOMER DETECTED AND CORRECTED THE RESULTS OF THE CHARTING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611587 ↗
• MalfunctionOct 11, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THEIR DXH520 CP HEMATOLOGY INSTRUMENT HAD GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF SERIOUS INJURY OR IMPACT TO PATIENT TREATMENT RELATED TO THIS EVENT. PRINTOUTS WERE REQUESTED MULTIPLE TIMES BUT NOT PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611580 ↗
• MalfunctionAug 24, 2021Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED ONE PATIENT SAMPLE RECOVERED WITH AN INCORRECT SPECIMEN IDENTIFICATION NUMBER AND PATIENT DEMOGRAPHIC COMPARED TO THE TUBE THEY CYCLED ON THE DXH520 CP HEMATOLOGY INSTRUMENT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. ERRONEOUS RESULTS WERE SENT TO THE LIS SYSTEM BUT THE ISSUE WAS CAUGHT BEFORE BEING REPORTED OUT OF THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363739 ↗
• MalfunctionApr 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING ERRONEOUS PLATELET (PLT) RESULTS ON A PATIENT SAMPLE AND INTERMITTENT SYRINGE VACUUM ERRORS ON THEIR DXH 520 HEMATOLOGY INSTRUMENT. CUSTOMER STATED THEY HAVE GOTTEN THE SYRINGE VACUUM ERROR SEVERAL TIMES IN THE PAST MONTH. CUSTOMER REPORTED THAT THEY HAD ONE SAMPLE THAT WAS NOT GIVING THE CORRECT RESULTS ON PLT. THE CUSTOMER SAID THE SAMPLE GAVE A RESULT OF 483 AND WHEN RERUN RESULTED IN 2353. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT WAS CONSISTENT FOR THE PATIENT AND CONSIDERED CORRECT. THE RESULTS FROM THE DXH 520 WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT THE DXH 520 HAD GENERATED ABNORMAL DIFF, CELLULAR INTERFERENCE, AND LARGE CELL MESSAGES. IT COULD NOT BE CONFIRMED IF BOTH OF THE RUNS GENERATED MESSAGES. PATIENT DATA WAS REQUESTED BUT HAS NOT BEEN PROVIDED. THE CUSTOMER LAB SAID THAT THE INITIAL COMPLAINANT HAS THE INFORMATION AND WILL BE OUT OF THE OFFICE FOR SEVERAL WEEKS. THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636161 ↗
• MalfunctionOct 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING ERRONEOUS HIGH PLATELET (PLT) RESULTS ON THREE (3) PATIENTS AND QC WHILE USING THEIR DXH 520 HEMATOLOGY INSTRUMENT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY, THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE CUSTOMER RAN THE QC VIALS ON THE MORNING OF THE OCCURRENCE AND THEY PASSED, EVEN THOUGHT THEY WERE EXPIRED. THE CUSTOMER BEGAN RUNNING SAMPLES AND 3 OF THE PATIENT SAMPLES HAD HIGH PLT RESULTS, THE CUSTOMER MIXED THE SAMPLES AND RE-RAN THEM. THE SECOND PLT RESULT WAS HIGHER THAN THE FIRST RUN. THE CUSTOMER DID NOT REPORT THE RESULTS OUT AND SENT THE SAMPLES OUT TO GET TESTED ELSEWHERE. THE RESULTS OF THE LAST RUN WERE REQUESTED BUT THE CUSTOMER SAID THEY DID NOT HAVE THOSE RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10615037 ↗
• MalfunctionSep 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE BECKMAN COULTER APPLICATIONS REPRESENTATIVE REPORTED THE CUSTOMER WAS NOT SCANNING THE BARCODE ON SPECIMEN TUBES PROCESSED ON THEIR DXH520 INSTRUMENT WHEN RUNNING SAMPLES IN PRIMARY (CLOSED VIAL) MODE. THE CUSTOMER WAS NOT CONFIRMING THE ¿NEXT SPECIMEN ID¿ WAS CORRECT OR MATCHING THE SAMPLE BEING PROCESSED, RESULTING IN PATIENT RESULT MISIDENTIFICATION. THE REPORTED FAILURE MODE OCCURRED WHEN THE OPERATOR DID NOT SCAN THE SAMPLE BAR CODE, NOR CONFIRMED THE NEXT SPECIMEN ID WAS CORRECT. THE OPERATOR ACKNOWLEDGED THE ¿OK¿ ICON ON POPUP WINDOW CONFIRMING THE ¿NEXT SPECIMEN ID¿ WAS CORRECT, THEN INSERTS THE MIXED SAMPLE INTO THE TUBE HOLDER AND PRESSES THE RUN ICON. SELECTING THE RUN ICON WILL CLOSE TUBE HOLDER DOOR AND INITIATE AN ANALYTICAL CYCLE. ON SUBSEQUENT SAMPLE RUNS, THE POPUP WINDOW: ¿VERIFY NEXT SPECIMEN ID IS NOT DISPLAYED¿." HOWEVER, AS SPECIMENS ARE PROCESSED, IF ANY ENTRY EXIST ON THE WORKLIST, THE NEXT SPECIMEN ID FIELD ON THE SAMPLE ANALYSIS. PATIENT RESULTS SCREEN AUTOMATICALLY DISPLAYS THE FIRST SPECIMEN ID FROM THE WORKLIST AS THE NEXT SPECIMEN TO BE PROCESSED. THE SPECIMEN ID IS USED TO MATCH THE RESULTS TO AN ENTRY ON THE WORKLIST. THERE WAS NO DEATH, OR INJUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541718 ↗
• MalfunctionSep 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE BECKMAN COULTER APPLICATIONS REPRESENTATIVE REPORTED THE CUSTOMER WAS NOT SCANNING THE BARCODE ON SPECIMEN TUBES PROCESSED ON THEIR DXH520 INSTRUMENT WHEN RUNNING SAMPLES IN PRIMARY (CLOSED VIAL) MODE. THE CUSTOMER WAS NOT CONFIRMING THE ¿NEXT SPECIMEN ID¿ WAS CORRECT OR MATCHING THE SAMPLE BEING PROCESSED, RESULTING IN PATIENT RESULT MISIDENTIFICATION. THE REPORTED FAILURE MODE OCCURRED WHEN THE OPERATOR DID NOT SCAN THE SAMPLE BAR CODE NOR CONFIRMED THE NEXT SPECIMEN ID WAS CORRECT. THE OPERATOR ACKNOWLEDGED THE ¿OK¿ ICON ON POPUP WINDOW CONFIRMING THE ¿NEXT SPECIMEN ID¿ WAS CORRECT; THEN INSERTS THE MIXED SAMPLE INTO THE TUBE HOLDER AND PRESSES THE RUN ICON. SELECTING THE RUN ICON WILL CLOSE TUBE HOLDER DOOR AND INITIATE AN ANALYTICAL CYCLE. ON SUBSEQUENT SAMPLE RUNS, THE POPUP WINDOW: ¿VERIFY NEXT SPECIMEN ID IS NOT DISPLAYED¿. HOWEVER, AS SPECIMENS ARE PROCESSED, IF ANY ENTRY EXIST ON THE WORKLIST, THE NEXT SPECIMEN ID FIELD ON THE SAMPLE ANALYSIS - PATIENT RESULTS SCREEN AUTOMATICALLY DISPLAYS THE FIRST SPECIMEN ID FROM THE WORKLIST AS THE NEXT SPECIMEN TO BE PROCESSED. THE SPECIMEN ID IS USED TO MATCH THE RESULTS TO AN ENTRY ON THE WORKLIST. THERE WAS NO DEATH OR INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541592 ↗