Roche cobas pro recall - Software defect

The FDA has classified a recall of Roche cobas pro integrated solutions, specifically the cobas pro sample supply unit and cobas pro SSU, as Class II. The issue stems from a software defect that allows the system to accept non-monotonous calibrations for Spline-type assays, potentially impacting the accuracy of clinical chemistry and immunochemistry results. The recall is ongoing and affects nationwide distribution within the United States.

Medical device manufacturers and healthcare providers utilizing these systems must be aware of this recall. While the document does not specify immediate actions for users, it implies a need to assess the impact of the software defect on assay results and potentially consult Roche Diagnostics for remediation or updates. The classification as Class II suggests that the use of the device may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.