UNICEL DXH 520 COULTER CELLULAR ANALYSIS SYSTEM
Received Feb 3, 2026 · Event occurred Jan 5, 2026
Report 1061932-2026-00004 · MDR key 24254885
Device
Generic name
Counter, Differential Cell
Manufacturer
Beckman Coulter Ireland IncModel number
TN DXH 520 CP HEMATOLOGY INSTRUMENTCatalog number
B40602
Product problems
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BECKMAN (BEC) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE, DISCUSSED BATH CLEANING PROCEDURE AND BLEACH USE, AND REPLACED THE RBC BATH ELECTRODE (PART RXH06071) TO RESOLVE THE ISSUE. DAILY CHECKS AND QUALITY CONTROL (QC) PASSED AFTER TROUBLESHOOTING ACTIVITY, VERIFYING INSTRUMENT IS OPERATING IN ITS VALIDATED STATE. BEC INTERNAL IDENTIFIER - (B)(4).
Description of Event or 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.