Company: Beckman Coulter Biomedical GmbH
Date of Enforcement Report: 07/14/2023
Class II
PRODUCT
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Recall Number:
Z-2144-2023
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
RECALLING FIRM/MANUFACTURER:
Beckman Coulter Biomedical GmbH
VOLUME OF PRODUCT IN COMMERCE:
146 systems
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
