UniCel DxH 600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15099590192242), received between Nov 20, 2017 and Oct 2, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

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.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR DXH 600 HEMATOLOGY INSTRUMENT WAS GENERATING ERRATIC RESULTS FOR WBC, HEMOGLOBIN (HGB), AND PLATELET (PLT) VALUES. THE CUSTOMER REPORTED DELAY TREATMENT FOR ONE PATIENT IN THE FORM OF A TRANSFUSION. ADDITIONAL DETAIL REGARDING THE CLINICAL IMPACT TO THE PATIENT WAS REQUESTED BUT NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 12849480 ↗
• MalfunctionJun 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TOTAL PLATELET VOTE OUTS (NON-NUMERIC REPLACEMENT CODES) ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS, DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725211 ↗
• MalfunctionJun 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PLATELET (PLT) VOTEOUT ON THEIR UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PLT VOTEOUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725095 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CORD OF THE BARCODE READER ON THE CUSTOMER'S DXH600 HEMATOLOGY INSTRUMENT BECAME ENTANGLED AROUND THE OPERATOR'S ANKLE AS SHE WAS TURNING AWAY FROM THE INSTRUMENT. THE OPERATOR FELL AND BROKE HER ARM. THERE WAS NO REPORT OF ERRONEOUS RESULTS BEING GENERATED BY THE INSTRUMENT. THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: Fracture, Arm

  MAUDE report 8401504 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED INCREASED PLATELET (PLT) RESULTS ON PATIENT SAMPLES. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT. NEITHER PATIENT OR RAW DATA WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Test Result

  MAUDE report 7728793 ↗
• InjuryNov 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE HOSPITAL'S BIOMEDICAL ENGINEER WAS SPRAYED IN THE FACE AND EYES WITH AN UNKNOWN VOLUME OF WASTE FLUID FROM THE DXH 600 INSTRUMENT. PER PHONE CONVERSATION ON (B)(6) 2017 THE CUSTOMER CONFIRMED THERE WAS A LEAK DUE TO A LOOSE FITTING ON THE INSTRUMENT WASTE LINE TO THE FLOOR DRAIN AT THE TIME OF THE EVENT. THE CUSTOMER STATED THAT THE UNIT WAS NOT OPERATIONAL WHILE ATTEMPTING TO CHANGE A FITTING. THE BIOMEDICAL ENGINEER WAS SPLASHED WITH A MIXTURE CONSISTING OF BLOOD AND REAGENTS ON BOARD THE INSTRUMENT AND WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES WITH NO EYE PROTECTION WHILE ATTEMPTING TO CHANGE THE FITTING ON THE WASTE LINE. PER SUBMITTER THE SITE'S EXPOSURE PLAN WAS IMMEDIATELY PLACED INTO EFFECT AT THE TIME OF THE INCIDENT. THE CUSTOMER SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 BY GOING TO THE EMERGENCY ROOM. THE CUSTOMER CONFIRMED THEY WERE NOT ADMITTED TO THE HOSPITAL BUT WAS ADMINISTERED DECONTAMINATION TREATMENT WHICH INCLUDED RINSING OF THE EYES FOR ONE HOUR. THE EYE RINSE WAS IMMEDIATELY FOLLOWED BY POST-EXPOSURE PROPHYLAXIS ANTIRETROVIRAL MEDICATION. THE CUSTOMER ALSO STATED FOLLOW UP BLOOD TEST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044899 ↗