China NMPA Product Recall - Ferritin Assay Kit (Heterogeneous Immunoassay) Ferritin Flex® reagent cartridge (FERR)

Siemens Healthcare Diagnostics Inc. has initiated a voluntary Class III recall concerning its Ferritin Flex® reagent cartridge (FERR), a critical component of the Ferritin Assay Kit (Heterogeneous Immunoassay). This significant regulatory action, communicated through the National Medical Products Administration (NMPA) and published on August 6, 2019, involves products distributed under National Medical Device Registration Certificate No. 20172401215. The recall was reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. The primary reason for this recall is cited as "the existence of the product in question," indicating an identified issue requiring corrective action, though the specific nature of the defect is not detailed in this announcement. A Class III recall designation, as defined by regulatory standards, signifies that the use of or exposure to the affected medical device is not expected to cause serious adverse health consequences. The company's required action involves the proactive removal of the identified product from the market. Further comprehensive details, including the specific models, specifications, and batch numbers of the impacted Ferritin Flex® reagent cartridges, are documented within an attached "Medical Device Recall Event Report Form" to ensure complete transparency and traceability. This measure underscores the company's commitment to product safety and regulatory compliance within the medical device sector.