FDA Enforcement
Class II
Ongoing
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Recall: Z-2145-2023
·
Reported July 26, 2023
Enforcement
- Recall Number
- Z-2145-2023
- Event ID
- 92484
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beckman Coulter Biomedical GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 26, 2023
- Initiation Date
- June 2, 2023
- Classification Date
- July 14, 2023
- Address
- Sauerbruchstr. 50, N/A, Munchen, N/A, N/A, Germany
Description
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
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 Info
UDI-DI: (01)15099590707118, All DxA serial numbers
Distribution
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,
Quantity
15