Roche Diagnostics Operations, Inc. is recalling 1,261 units of the cobas pro integrated solutions analyzer due to a software defect. The system may accept incorrect calibrations for certain Spline-type assays, causing the instrument to fail to calculate new values and instead repeat the last successful result for all subsequent patient tests. This issue affects eight specific laboratory assays used for various clinical measurements. Roche has initiated this voluntary recall through a notification letter to affected laboratories and healthcare facilities.
The software defect causes the system to produce identical and erroneous patient results across multiple tests, which can lead to misdiagnosis or incorrect treatment plans. While the manufacturer considers the risk of serious health consequences to be remote, inaccurate lab data poses a direct threat to patient safety.
Affected software: all versions previous to 03-02. Affected assays include: CYSC2 (20510), FER4X (20571), LPA2X (20861), LPA2-X (20864), VANC3O (21211), KFLCX (21421), LFLC (21430), and FCAL (21490).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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