FDA Warns That Software Fix for Beckman Coulter Devices Has Not Been Evaluated


The Food and Drug Administration (FDA) is warning that it has not evaluated the software fix for Beckman Coulter medical devices. The devices are intended to flag inaccurate results from its blood test analyzers.

Beckman Coulter told customers that the software update may alert laboratory personnel to inaccurate results. The FDA says that it is working with the company to determine whether the software update is enough to fix the faulty devices.

The devices are used by large medical centers, community hospitals and other facilities as part of pre-surgical assessments, routine check-ups and to identify patients who may need platelet transfusions.

Beckman Coulter told customers in 2018 that it had evidence the devices were providing false results without issuing an error alert. Some of the labs failed to reply to the notice.

The FDA is warning healthcare professionals to be aware of potentially inaccurate results. To mitigate adverse consequences, the agency is asking healthcare professionals to use backup analyzers or manual platelet screening estimates.

Devices affected by the recall include Beckman Coulter DxH 800, DxH 600 and DxH 900. These blood test analyzers help doctors diagnose conditions and diseases, such as blood clotting problems, anemia, blood cancers, infections and immune system disorders.

Inaccurate results could have serious health risks for patients. A provider may conclude that a patient is suitable for surgery when they may not be. Providers may conclude that platelet transfusions should be withheld when they shouldn’t be.

The company is working on a fix for the problem, but it has not yet determined the root cause. While the work is ongoing, the Beckman Coulter is asking users not to perform the procedure. The company will be rolling out an algorithm designed to detect and flag false results as they happen. The software fix was available in October, but the FDA has not evaluated whether the update is enough to address the recall issues.