China NMPA Product Recall - Coagulation quality control product Con P+

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its coagulation quality control product, Con P+, as announced on December 4, 2020. This action, overseen by the National Medical Products Administration (NMPA) in China, addresses a specific technical issue identified with certain product batches. The primary concern arose when batches of Con P+ (including 39357701, 41243701, 43632201, and 45826201) were utilized in conjunction with the thrombin time assay kit (batch 47314601). Under these conditions, customers reported that the recovery rate for the coagulation quality control product reached or exceeded its upper limit, indicating a potential for inaccurate measurement results. Despite this deviation in performance, Roche Diagnostics has confirmed that patient diagnostic outcomes remain unaffected, and any associated medical risks have been successfully mitigated. To resolve the issue and enable continued normal use, the company requires the reallocation of the target value corresponding to the specific reagent batch number. This proactive recall demonstrates the company's commitment to product quality and patient safety, aligning with NMPA's regulatory expectations. Further details regarding affected product models and specifications are accessible via the "Medical Device Recall Event Report Form".