China NMPA Product Recall - Amylase assay using dry slides (rate method)

On June 4, 2020, Ortho-Clinical Diagnostics (China) Co., Ltd., acting on behalf of Orsendo Clinical Diagnostics (USA) Inc., announced a voluntary Class II recall of its Amylase Assay Dry Tablets (Rate Method). The decision stemmed from observed imperfections in the product's performance when used for quality control and patient sample analysis. Specifically, investigations revealed that standard deviations exceeded the estimated intra-laboratory standard deviations in VITROS quality control test sheets at some facilities, indicating potential reliability concerns. This recall falls under the regulatory purview of the National Medical Products Administration (NMPA) of China, with the announcement originating from the Shanghai Municipal Drug Administration website. The NMPA's framework mandates such actions to safeguard public health and ensure the reliability of medical devices. The primary required action by the company is the immediate withdrawal of the affected product from the market. Comprehensive details concerning the specific product models, specifications, and batch numbers involved are provided in the associated 'Medical Device Recall Event Report Form' to facilitate proper handling and compliance.