Device product
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Z-2145-2023
Product summary
- Event
- Event 92484
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-2145-2023
Official wording
Reason: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
Code information: UDI-DI: (01)15099590707118, All DxA serial numbers
Distribution pattern: US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,
Derived failure modes
-
Device software or design
software defect