UniCel DxHRecalls & reported problems across all models

We found 4 models of UniCel DxH by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2016 and Mar 11, 2026 — classified as 21 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (27 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

UniCel DxH recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 13, 2025Open, Classified

   Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

   Z-2575-2025 · Root cause: Component change control · Recall details · FDA record ↗

2. Aug 13, 2025Open, Classified

   Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

   Z-2574-2025 · Root cause: Component change control · names 2 of these models · Recall details · FDA record ↗

Most reported UniCel DxH problems

UniCel DxH models

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

• UniCel DxH 800

  Counter, Differential Cell
  1 recall33 reports
• UniCel DxH 800

  Counter, Differential Cell
  1 recall26 reports
• UniCel DxH 600

  Counter, Differential Cell
  1 recall10 reports
• UniCel DxH SMS

  Slide Stainer, Automated
  5 reports

Recent UniCel DxH adverse event reports

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

• InjuryMar 11, 2026Device Handling Problem

  DURING REMOVAL OF THE SAMPLE TRANSPORT MODULE (STM) ON THE UNICEL DXH SLIDEMAKER STAINER (PRODUCT NUMBER: 775222, SERIAL NUMBER: (B)(6) , THE MODULE BECAME LODGED ON THE GUIDE RAIL. THE BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO RESET THE STM, AT WHICH POINT IT UNEXPECTEDLY DISENGAGED AND BEGAN TO FALL. THE FSE INTERVENED TO PREVENT THE MODULE FROM DROPPING, RESULTING IN A MUSCLE STRAIN TO THE LEFT SHOULDER AND UPPER BACK. THE INJURY WAS NOT IMMEDIATELY APPARENT AT THE TIME OF THE INCIDENT BUT PROGRESSIVELY WORSENED DURING THE FSE¿S DRIVE HOME. THE FSE REPORTED THE INCIDENT TO THEIR SUPERVISOR AND CONTACTED THE MEDICAL CALL CENTER TO SEEK MEDICAL EVALUATION AND GUIDANCE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 24574846 ↗
• InjuryFeb 10, 2026Output Problem

  THE CUSTOMER REPORTED THAT THEIR DXH800 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUSLY LOW PLATELET (PLT) RESULTS FOR A PATIENT WITH A MALIGNANT HEMATOPATHY (MYELODYSPLASIA). THE INITIAL PLT RESULT WAS APPROXIMATELY 10 G/L AND WHEN THE PATIENT UNDER WENT TESTS IN ANOTHER LABORATORY THE RESULTS WAS ABOVE 20G/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BECAUSE OF THEIR PRE-EXISTING CONDITION, THE PATIENT RECEIVED TRANSFUSIONS BASED ON THE PLT RESULT. WHEN THE PLT VALUE IS >20 G/L IT DOES NOT LEAD TO TRANSFUSION, WHEN THE RESULTS IS 10 G/L, THE PATIENT IS SYSTEMATICALLY TRANSFUSED. THE PATIENT WAS SYSTEMATICALLY TRANSFUSED BASED ON THE DXH800 RESULTS OF APPROXIMATELY 10 G/L. THE CUSTOMER STATED THAT THIS DIFFERENCE REPRESENTS A SIGNIFICANT CLINICAL DISCREPANCY. THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS; HOWEVER, NO ADVERSE EFFECTS OR CLINICAL COMPLICATIONS RELATED TO THE TRANSFUSIONS WERE OBSERVED. THE PATIENT DATA PROVIDED BY THE CUSTOMER SHOWS THAT THE RESULTS WERE FLAGGED WITH 'R' FLAGS THAT PROMPT THE OPERATOR TO REVIEW THE RESULTS BEFORE RELEASIING THEM OUT OF THE LABORATORY. THE FLAGGED RESULTS WERE RELEASED WITHOUT ADDITIONAL VERIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310432 ↗
• MalfunctionOct 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR DXH600 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUS PLATELET (PLT), HEMOGLOBIN (HGB), WBC AND RBC RESULTS WITH PARTIAL ASPIRATION (P) ERRORS ON PATIENT SAMPLES. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR CHANGE TO TREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353476 ↗
• MalfunctionAug 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THE UPS POWERVAR CONNECTED TO THE DXH600 INSTRUMENT CAUGHT FIRE WITH VISIBLE FLAMES DURING NORMAL INSTRUMENT OPERATION. THE CUSTOMER ALSO REPORTED THE DXH600 WAS NOT AFFECTED BY THE EVENT. HOWEVER, THE UPS WAS DESTROYED. THE LABORATORY WAS EVACUATED. THE FIRE DEPARTMENT WAS CALLED. THE FIRE DEPARTMENT USED A FIRE EXTINGUISHER TO PUT OUT THE FIRE. NO INJURIES REPORTED DUE TO THE EVENT. 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. THE FAILURE MODE IS UNKNOWN. HOWEVER, THE ISSUE WAS RESOLVED BY CONTACTING THE UPS MANUFACTURER, PLUGGING THE INSTRUMENT AND DEVICES DIRECTLY INTO A RED OUTLET IN THE LABORATORY, POWERING OFF/ON THE ANALYZER AND PERFORMING DAILY CHECKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958306 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BEC FIELD SERVICE MANAGER REPORTED THAT A BEC FIELD SERVICE ENGINEER (FSE) WAS INJURED WHILE TROUBLESHOOTING THE CUSTOMER¿S DXH 800 HEMATOLOGY INSTRUMENT. DURING TROUBLESHOOTING THE CUSTOMER'S DXH 800 HEMATOLOGY INSTRUMENT, THE FSE INJURED HIS RIGHT SHOULDER DUE TO LIFTING A COVER ON THE INSTRUMENT SEVERAL TIMES. THE DOOR NEEDS TO BE REMOVED EACH TIME TO SERVICE THE AREA AND NEEDED TO BE PLACED BACK ON TO ENGAGE THE SAFETY MEASURES ON THE UNIT. PER INCIDENT REPORT (B)(4), THE FIELD SERVICE MANAGER INDICATED THAT THE FSE PLACED THE RIGHT HAND ON BACK OF INSTRUMENT DOOR FROM LOWER RIGHT, WITH THE LEFT HAND ON TOP OF THE LEFT FRONT SIDE OF THE DOOR, LIFTED DOOR WITH BOTH HANDS AND FELT POPPING IN RIGHT SHOULDER. THE FSE WAS INITIALLY SEEN BY THEIR PRIMARY CARE PHYSICIAN (PCP) ON (B)(6) 2024. THE PCP DID NOT PROVIDE A DIAGNOSIS AND IMAGING WAS NOT DONE OF THE AFFECTED AREA. THE FSE WAS INSTRUCTED TO USE OVER THE COUNTER (OTC) CREAM FOR PAIN RELIEF AND TOLD TO FOLLOW UP WITH AN ORTHOPEDIC SPECIALIST AND GET X-RAYS OF THE AFFECTED AREA. THERE WERE NO WORK RESTRICTIONS REQUIRED BY THE PCP. THE FSE RECEIVED X-RAYS ON (B)(6) 2024 AND THE RESULTS OF THE IMAGING WERE CONSIDERED NORMAL. ON

  Patient problems: Pain

  MAUDE report 19934793 ↗
• MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCORRECT RESULT / FALSE H & H CRITICAL RESULT FLAGGED /WBC /RBC /HGB/HCT/ MCH/MCHC / PLATELETS HIGHER // ON ONE SAMPLE. THERE WERE INDICATIONS OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY, LEADING TO ONE PATIENT RECEIVING ONE UNIT OF BLOOD. THE ERRONEOUS RESULTS WERE NOT CONFIRMED BY THAT LABORATORY AND IT IS UNKNOWN IF THAT TRANSFUSION WAS REQUIRED. NO PATIENT HISTORY WAS AVAILABLE. THERE WAS NEITHER DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO SUFFICIENT EVIDENCE THAT REASONABLY SUGGESTS A MALFUNCTION. BASED ON THE SERVICEMAX SERVICE REQUEST CA-06603370 DATED MARCH-09-2024, THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER'S REPORTED ISSUE. THE CTS CONFIRMED THIS ISSUE WAS ISOLATED TO ONE PATIENT SAMPLE. THE REPORTED ISSUE COULD NOT BE REPRODUCED BY THE CTS, AND NO INSTRUMENT MALFUNCTION WAS IDENTIFIED. THE CUSTOMER AGREED WITH THE SOLUTION AND DID NOT CALL BACK TO REPORT ANY ISSUES. SERVICE RECORDS FOR THE INSTRUMENT HAVE BEEN REVIEWED AND THERE IS NO REPORT OF A RECURRENCE OF THIS EVENT BY THE CUSTOMER. SYSTEM WAS VERIFIED TO MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE SYSTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050981 ↗
• MalfunctionOct 19, 2023Output Problem; Output Problem

  THE CUSTOMER STATED THEIR DXH 600 HEMATOLOGY INSTRUMENT REPORTED H&H FAILED MESSAGE AND ERRONEOUS RESULTS ON ONE PEDIATRIC SAMPLE WHEN RUN IN OPEN TUBE MODE. LOW HEMOGLOBIN (HGB )RESULTS, AS WELL AS HIGH RBC, WBC, AND PLT (PLATELET) RESULTS WERE PRODUCED. THIS INSTRUMENT GENERATED LOW MCHC RESULT AND H&H FAILED USER DEFINED MESSAGES. CORRECT RESULTS WERE OBTAINED WHEN SAMPLE WAS RUN IN CLOSED TUBE MODE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT OR OPERATOR AS A RESULT OF THIS EVENT. PATIENT DATA WAS PROVIDED FOR THE SAMPLE IN QUESTION. ALL PARAMETERS SHOW DIFFERENCES BETWEEN THE ERRONEOUS RESULTS GENERATED WHEN RUN IN THE OPEN TUBE MODE AND THE CORRECT CLOSED TUBE MODE. NO INSTRUMENT GENERATED FLAGGING WAS OBSERVED FOR THE ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971361 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BEC EMPLOYEE (FIELD SERVICE ENGINEER, FSE) REPORTED THAT WHILE TROUBLESHOOTING ON DXH SMS, HE SUFFERED A LOWER BACK INJURY WHEN REINSTALLING THE DXH SMS SAMPLE TRANSPORT MODULE (STM). THE FSE STATED HE IMMEDIATELY NOTIFIED HIS MANAGER AND CALLED THE EMPLOYEE NURSE HOTLINE. THE HOTLINE SCHEDULED A DOCTOR'S APPOINTMENT FOR NEXT DAY ON ((B)(6) 2023). THE FSE STATED HE WAS ADMINISTERED A TORADOL INJECTION AND PRESCRIBED METHYL PREDNISOLONE, AND THE DOCTOR REQUESTED AN MRI TO EVALUATE THE SEVERITY OF THE CONDITION. THE FSE WAS OUT FOR TWO WEEKS ON WORKMAN'S COMPENSATION.

  Patient problems: Pain

  MAUDE report 17908912 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED APPROXIMATELY FIVE PATIENT SAMPLES RECOVERED WITH HIGH RBC AND PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH800 INSTRUMENT COMPARED TO ALTERNATE INSTRUMENT. MEAN CORPUSCULAR VOLUME (MCV) RESULTS WERE ALSO DISCORDANT BETWEEN INSTRUMENTS. NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PRINTOUTS OF THE EVENT REQUESTED BUT NOT PROVIDED. PLATELET AND RBC SUSPECT MESSAGING COULD NOT BE VERIFIED. MANUAL SMEAR RESULTS WERE REQUESTED BUT WAS NOT AVAILABLE FOR REVIEW. THE CUSTOMER PERFORMED AN APERTURE CLEANING. HOWEVER, THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389977 ↗
• MalfunctionFeb 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELET (PLT) RESULTS WERE GENERATED ON FOUR PATIENT SAMPLES ON THEIR DXH 800 HEMATOLOGY INSTRUMENT WHEN COMPARED TO RUNS ON OTHER INSTRUMENTS. OF THE FOUR RESULTS THAT GENERATED ERRONEOUS HIGH PLT TWO OF THE RESULTS GENERATED RBC FRAGMENT FLAGS. THE OTHER TWO RESULTS DID NOT GENERATE ANY FLAGS. 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 16298883 ↗
• MalfunctionJan 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELETS (PLT) RESULTS WERE GENERATED ON PATIENT SAMPLES ON THEIR DXH 800 INSTRUMENT WHEN COMPARED TO RERUNS ON ANOTHER INSTRUMENT. A PRINTOUT PROVIDED BY THE CUSTOMER SHOWS THAT A SAMPLE RUN ON THE INSTRUMENT GAVE A PLT RESULT OF 94 WITH NO FLAGS AND WAS CONSIDERED ERRONEOUS. THE CUSTOMER RERAN THE SAMPLE AFTER TROUBLESHOOTING AND THE INSTRUMENT GAVE A PLT RESULT OF 65 WHICH WAS CONSIDERED CORRECT. 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 16243866 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED SHE SCRATCHED HER RIGHT FOREARM WHILE TRYING TO REMOVE A SLIDE THAT FELL INSIDE THEIR DXH SLIDEMAKER STAINER (SMS) INSTRUMENT. THE WOUND ON THE FOREARM WAS A SUPERFICIAL SCRATCH THAT DID NOT REQUIRE MEDICAL INTERVENTION OR ANY WORK RESTRICTIONS. THE OPERATOR WAS ADMINISTERED RETROVIRALS AS A PREVENTATIVE MEASURE AND WAS TESTED FOR HIV AND OTHER VIRUSES ON THE DAY OF EXPOSURE. THE OPERATOR WAS ALSO SCHEDULED FOR A 30-DAY FOLLOW-UP.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15459288 ↗
• InjuryJun 3, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED WHILE REPLACING THE RETIC PACK ON THEIR DXH 600 HEMATOLOGY INSTRUMENT, THE PICK UP TUBE FLICKED A DROP OF RETIC CLEAR REAGENT INTO THE TECHNICIAN¿S RIGHT EYE. THE TECHNICIAN WAS WEARING LAB COAT AND GLOVES (NO FACE PROTECTION) AT TIME OF EXPOSURE. THE TECHNICIAN FLUSHED HIS EYE WITH WATER, STATING THERE WAS NO IRRITATION OR VISION ISSUE. PER LAB EXPOSURE PROTOCOL, WENT TO THE EMERGENCY DEPARTMENT (ED) TO HAVE HIS EYE CHECKED. THE ED NOTED NO REAL (EYE) DAMAGE AND PRESCRIBED THE LAB TECH AN ANTIBIOTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596064 ↗
• MalfunctionApr 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THROMBOCYTOPENIC PATIENT SAMPLES RECOVERED WITH HIGHER PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH 800 HEMATOLOGY INSTRUMENT (DXH800-3) COMPARED TO ALTERNATE DXH800 INSTRUMENTS. 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. PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 1) RECOVERED WITH HIGHER PLATELET RESULTS FROM THE DXH800-3 COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. NO SUSPECT MESSAGING ON EITHER RUN. PRINTOUTS ALSO RECEIVED INDICATED TWO PATIENT SAMPLES (SAMPLE 2 AND SAMPLE 3) RECOVERED WITH HIGHER PLATELET RESULTS FROM THE DXH800-3 COMPARED TO RERUNS ON ALTERNATE INSTRUMENTS THE CUSTOMER BELIEVES TO BE CORRECT. IT IS UNKNOWN IF EITHER RUN RECOVERED WITH SUSPECT MESSAGING. THE NEXT SET OF PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 4) RECOVERED WITH HIGHER PLATELET RESULTS FROM THE DXH800-3 COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. BOTH RUNS RECOVERED WITH SUSPECT MESSAGING. THE LAST PRINTOUTS RECEIVED (SAMPLE 5) RECOVERED WITH HIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186889 ↗
• MalfunctionFeb 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PATIENT SAMPLES RECOVERED WITH HIGH PLATELET (PLT) RESULTS AND NO SUSPECT MESSAGING WHEN CYCLED ON THEIR UNICEL DXH800 INSTRUMENT COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT. PRINTOUTS OF THE EVENT WERE REQUESTED, BUT NOT PROVIDED. 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 13544410 ↗

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