China NMPA Product Recall - EGFR gene mutation detection kit (allele-specific amplification fluorescent PCR method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its EGFR Gene Mutation Detection Kit (Allele-Specific Amplification Fluorescent PCR Method) on September 26, 2021. This action was prompted by customer feedback indicating the potential for false exon20 insertion mutation detection results when using the kit. Specifically, the observed data showed inaccurate readings for low positive samples concerning Ex20Ins false mutations, which could potentially impact diagnostic accuracy for patients. This recall is being conducted under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. A Class II recall signifies that the use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As part of the required actions, Roche Diagnostics is actively retrieving the affected kits. Comprehensive details regarding the specific product models, specifications, and batch numbers subject to this recall are thoroughly documented in the accompanying "Medical Device Recall Event Report Form," accessible to all stakeholders. This proactive measure underscores the company's commitment to ensuring the reliability and safety of its diagnostic products within the medical community.