Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

On March 11, 2019, the firm notified affected consignees of the product issue through an Urgent Medical Device Correction letter. Customers were informed that they may observe a decrease in recovered concentration for NTproBNP in the referenced Liquid Cardiac Control lots compared to the quoted target value on the value sheet for this analyzer only (Siemens Dimension EXL LOCI). Customers were asked to do the following: * Inspect your stock and quarantine affected stock. " Replace the value sheet in the kit with the revised value sheet provided. " Randox is not recommending a review of previous results as changes in quality control recovery would be reviewed at the time of occurrence. " Discuss the contents of this notice with your Medical Director. " Complete the response form even if you no longer have the affected product. Return the response form to technical.services@randox.com within five working days.