UNICEL DXH 560 AL COULTER CELLULAR ANALYSIS SYSTEM
Received Jun 16, 2026 · Event occurred May 21, 2026
Report 1061932-2026-00010 · MDR key 25518921
Device
Generic name
Counter, Differential Cell
Manufacturer
Beckman Coulter Ireland IncModel number
DXH 560 AL HEMATOLOGY ANALYZERCatalog number
B40603
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BECKMAN (BEC) FIELD SERVICE ENGINEER (FSE) REPLACED THE SYRINGE BODY, BUT THIS DID NOT RESOLVE THE ISSUE. THE FSE REPLACED THE RBC COUNT CHAMBER (PART RXH60035) AND ALSO REPLACED THE VALVE. REPEATABILITY WAS PERFORMED AND 20 SAMPLES WERE RUN WITHOUT ISSUE. VERIFICATION OF ACTIVITY: REPEATABILITY, DAILY CHECKS AND CONTROLS PASSED. BEC INTERNAL IDENTIFIER - (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED PLATELET (PLT) RESULT VARIATION ON THE DXH 560 AL HEMATOLOGY INSTRUMENT (PRODUCT NUMBER: B40603, SERIAL NUMBER: (B)(6). ERRONEOUSLY LOW AND HIGH PLT RESULTS WERE GENERATED. THERE WAS NO REPORT OF AN ADVERSE EVENT. THERE WAS NO REPORT OF DEATH, SERIOUS 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. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ON-SITE SERVICE WAS SCHEDULED.