Medical device manufacturer, Roche, has issued a medical device safety alert concerning its urea/ blood urea nitrogen (UREA/BUN) for Modular system. The affected reference numbers are 11729691216, 11929470216, 11929488216, 11929496216, 11929500216 and 11489364216.
According to the manufacturer, rounding error occurred during calculation of measuring ranges and technical limits in different units. The error leads wrong measuring ranges and technical limits being stated in the Instruction of Use and setting in the analyzers. Thus, these values have to be corrected as well as harmonized in case where the values stated in the parking insert and setting is not coherent
The manufacturer has corrected the measuring range and technical limit for urea/urea nitrogen assay and harmonized in the packing insert as well as in the settings for serum and urine for MODULAR ANALYTICS P and D.
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 9 April 2015