Medical device manufacturer, Philips, has issued a medical device safety alert concerning its Inorganic Phosphorus [Reference: OSR6x22 Lot: All lots]
During internal interference testing, Inorganic Phosphorus failed to meet the haemolytic interference specification for the serum application. According to the manufacturer, the low analyte concentration pool tested (~0.7 mmol/L) exhibited a positive bias with a maximum bias of 24.02% at 3.5 g/L haemolysate. This positive bias is contributed to by phosphorus release from haemolysed cells.
There is a remote probability that a clinically significant interference due to pre-analytical hemolysis may cause falsely raised Inorganic Phosphorus results at low levels of Inorganic Phosphorus. According to the manufacturer, the risk of harm is highly unlikely.
The manufacturer advise all customers to update the hemolysis influence check settings on AU / DxC AU analysers. Furthermore, they will also update the IFU to remove existing serum haemolysis claim.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 27 Aug 2021