UniCel DxH SMSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15099590192679), received between Aug 23, 2019 and Mar 11, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Output Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMar 5, 2020Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE (PATIENT (B)(6)) SHOWED "VARIANTLY' ON THE RESULTS FROM THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WAS RUN ON THE DXH SMS FOR SLIDE ASSESSMENT. THE SLIDE RESULT REPORTED 11% BLASTS. FIVE DAYS LATER (B)(6) 2020 A BONE MARROW BIOPSY WAS PERFORMED AND WAS NEGATIVE. THIS WAS FOR A FOLLOW UP FOR A PATIENT WITH MULTIPLE MYELOMA (TYPE IGG KAPPA) IN REMISSION. PATIENT WAS CLINICALLY ASYMPTOMATIC. PATIENT (B)(6) RESULTS FROM THE DXH INSTRUMENT SHOWED VARIANT LYMPHOCYTIC POPULATION WHICH TRIGGERED THE SLIDE ORDERED ON THE DXH SMS. THE SLIDE SHOWED 11% BLAST. ON THE SAME DAY, THE SAMPLE WAS RUN THROUGH A FLOW CYTOMETRY INSTRUMENT AND THE EXAMINATION OF THE SAMPLE WAS NEGATIVE FOR BLAST. AS A RESULT OF THE POSITIVE SLIDE RESULTS, THE DOCTOR PERFORMED A BONE MARROW BIOPSY WHICH WAS NEGATIVE FOR BLASTS.

  Patient problems: Test Result

  MAUDE report 9795964 ↗
• InjuryAug 23, 2019Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD GENERATED WBC CARRYOVER AND VARIABLE LYMPH MESSAGES WHILE RUNNING A PATIENT SAMPLE. THIS PROMPTED A MANUAL SLIDE ASSESSMENT FOR THE PATIENT AND AS A RESULT OF THE SLIDE, THE PATIENT WAS THOUGHT TO HAVE RELAPSED AND A BONE MARROW DRAWING WAS DONE. THE SAMPLE WAS FOR A (B)(6) YEAR OLD FEMALE PATIENT WITH ACUTE MYELOID LEUKEMIA (AML). IT WAS CONFIRMED THAT THE PATIENT HAD NOT RELAPSED AS INITIALLY SUSPECTED. THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT COMPLICATION. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THERE NO MALFUNCTION OF THE DXH800 AS ORIGINALLY REPORTED. THE MALFUNCTION WAS IDENTIFIED TO HAVE TAKEN PLACE ON THE DXH SLIDEMAKER STAINER. THE EVENT THAT TRIGGERED THE LAB¿S RECOGNITION OF THE ISSUE WAS NEITHER THE RECIPIENT BONE MARROW BIOPSY RESULTS NOR A SECOND CARRYOVER EVENT, BUT RATHER TESTING OF A NEW SAMPLE FROM THE RECIPIENT PATIENT ON (B)(6). HER RESULTS FROM THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WERE CONSISTENT WITH RESULTS FROM (B)(6), BUT HER PERIPHERAL SMEAR PREPARED ON THE SMS DISCLOSED NO BLASTS. A SENIOR TECH AT THE LABORATORY RECOGNIZED THE SIGNIFICANCE OF

  Patient problems: Test Result

  MAUDE report 8927478 ↗