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Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Recalled July 26, 2023 · FDA recall Z-2144-2023 · Beckman Coulter Biomedical
Hazard
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 · FDA Class II
Units
146 systems
Sold at
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,
Description
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
Product
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Manufacturer(s)
Beckman Coulter Biomedical GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →