China NMPA Product Recall - Alkaline phosphatase series test reagents

Tosoh (Shanghai) Biotechnology Co., Ltd. initiated a global Class III voluntary recall for numerous alkaline phosphatase series detection reagents, as reported to the National Medical Products Administration (NMPA) on August 4, 2016. The recall addresses a critical diagnostic inaccuracy: when these test kits are used on samples from patients receiving low alkaline phosphatase treatment drugs, specifically Asfotase alfa, the drug adsorbs onto the kit components. This interference leads to false high values in sandwich method tests and false low values in competitive method tests. The affected products encompass a wide array of AIA series test kits, including those for tumor markers, hormones, and infectious diseases, among others. Although the manufacturer, Tosoh Corporation, noted that Asfotase alfa was not approved in China at the time and no health harms had been reported domestically, the company proceeded with the recall as a responsible measure. Required actions involve a global recall of all identified affected product batches, with communication disseminated to distributors via email for subsequent notification to end-users.