Jul

2023

FDA Recall: Software Defect May Lead to Erroneous Results

Allison Pate

News

fda, recall

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Defect May Lead to Erroneous Results

Allison Pate

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