Z-2145-2023 Class II Ongoing
FDA device recall Z-2145-2023 was initiated by Beckman Coulter Biomedical GmbH on June 2, 2023 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 15.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- June 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
Product Description
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Reason for Recall
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
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,
Code Information
UDI-DI: (01)15099590707118, All DxA serial numbers