Roche Diagnostics is recalling 458 units of the cobas HCYS Homocysteine Enzymatic Assay (Lot 747029) used on cobas c 701/702 laboratory analyzers. Abnormal calibration signals and control issues can cause the assay to produce incorrect homocysteine levels in patients, resulting in values that are either too high or too low. To date, no injuries or incorrect medical treatments have been reported due to this issue. Laboratory personnel should stop using the affected lot immediately and contact the manufacturer to arrange for a replacement.
Incorrect homocysteine test results can lead to medical misdiagnosis or inappropriate treatment monitoring for conditions such as vitamin deficiencies or cardiovascular risk. Because the results may be biased high or low, healthcare providers might make clinical decisions based on inaccurate data.
For use on cobas c 701/702 systems.
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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