China NMPA Product Recall - Immunoglobulin M Detection Kit (Immunoturbidimetric Assay)

On May 20, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall of its Immunoglobulin M Detection Kit (Immunoturbidimetric Assay). This action was reported under the National Medical Products Administration (NMPA) Administration Index No. JGXX-2019-10322. The recall stems from a product performance issue where the detection kit may generate specific error messages, E60 ("no reaction, antigen overload detection failure") or E66 ("unstable reaction"), when used to test patient samples with very low concentrations. It is important to note that this issue is specifically linked to the appearance of these error messages and does not reportedly impact the accuracy of results for patient samples that do not trigger such errors. In response to this identified issue, Beckman Coulter Trading (China) Co., Ltd. proactively engaged in this voluntary recall to address the potential for misleading error messages during testing. The company has made detailed information regarding the affected product models, specifications, and batch numbers available in an accompanying "Medical Device Recall Event Report Form" for stakeholders and customers to review. This measure ensures transparency and facilitates the appropriate handling of the affected kits in accordance with regulatory expectations set by the NMPA.