China NMPA Product Recall - Ceruloplasmin Assay Kit (Immunoturbidimetric Method)

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Ceruloplasmin Assay Kit (Immunoturbidimetric Assay) on June 24, 2019. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a significant product issue. The main reason for the recall is the incompatibility of EDTA sample types with the assay kit, which could potentially compromise the accuracy and reliability of diagnostic test results. The affected product, identified by Registration Certificate No. 20163400452, is being removed from the market. A Class III recall signifies that exposure to the product is not likely to cause adverse health consequences, yet the company is taking proactive steps to correct the identified technical flaw. Further details regarding specific models, specifications, and batch numbers are available in the attached "Medical Device Recall Event Report Form." This recall highlights the ongoing commitment to maintaining the quality and safety of medical devices within the regulatory framework.