Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning the following products:
The IFUs (Instructions for Use) for Vancomycin on cobas c 311/501/502 and MODULAR ANALYTICS P-MODULE state an incorrect method comparison against COBAS INTEGRA 800. Since the COBAS INTEGRA reagent is not yet adapted, results generated with COBAS INTEGRA are still up to 20 % higher than with cobas c or MODULAR ANALYTICS P-MODULE. The method comparison shown may lead to the assumption that both methods are comparable and may affect the interpretation of Vancomycin test results.
The issue can potentially lead to misinterpretation of results. In case that the first result has been generated with INTEGRA and the following result using cobas/Hitachi assay, the difference between assays might be interpreted as decrease in vancomycin concentration which can further trigger the increase in the dosage. In this case, a medical risk of toxic effects due to the increased vancomycin dosage cannot be excluded.
Incorrect method comparison will be deleted from the IFUs. Affected users are instructed to ignore the wrong method comparison in the IFUs.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 May 2016