STATSPIN EXPRESS 4 CENTRIFUGE
Received Mar 4, 2026 · Event occurred Feb 2, 2026
Report 2050012-2026-00014 · MDR key 24510424
Device
Generic name
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Manufacturer
Beckman Coulter Inc.Model number
EXPRESS 4 CENTRIFUGECatalog number
X00-005531-001
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE ROTOR OF THE STATSPIN EXPRESS 4 CENTRIFUGE BROKE DURING OPERATION, RESULTING IN BROKEN ROTOR PIECES TO FLY OUT OF CENTRIFUGE. THE CUSTOMER ALSO INDICATED THAT THE CENTRIFUGE COVER, SHIELD AND HOUSING BECAME DETACHED FROM THE ASSEMBLY. THE CUSTOMER CONFIRMED THERE WAS NO INJURY, EXPOSURE OR DEATH ASSOCIATED TO THIS EVENT.
Additional Manufacturer Narrative
A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT SPECIALIST (CTS) ASSISTED CUSTOMER TROUBLESHOOT OVER THE PHONE. THE CUSTOMER REPORTED THAT THE ROTOR OF THE STATSPIN EXPRESS 4 CENTRIFUGE BROKE DURING OPERATION, RESULTING IN BROKEN ROTOR PIECES TO FLY OUT OF CENTRIFUGE. THE CUSTOMER ALSO INDICATED THAT THE CENTRIFUGE COVER, SHIELD AND HOUSING BECAME DETACHED FROM THE ASSEMBLY. THE CUSTOMER CONFIRMED THERE WAS NO INJURY, EXPOSURE OR DEATH ASSOCIATED TO THIS EVENT. CTS RECOMMENDED CUSTOMER REPAIR OR REPLACEMENT OF THE ROTOR TO RESOLVE THE ISSUE. SECTION H6 COMPONENT CODE 4756 IS USED FOR ROTOR ASSEMBLY. THE BECKMAN COULTER IDENTIFIER IS (B)(4).