China NMPA Product Recall - Lactate assay kit (colorimetric method), Immunoglobulin M assay kit (immunoturbidimetric method) Tina-quant IgM Gen.2 (IGM-2), Total bilirubin assay kit (diazo method)

On January 16, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall affecting several of its key medical diagnostic products. This action, overseen by the National Medical Products Administration (NMPA), addresses an issue identified through the company's internal quality assessment processes. The affected products include the Lactate Assay Kit (Colorimetric Method), the Tina-quant IgM Gen.2 (IGM-2) Immunoglobulin M Assay Kit, and the Total Bilirubin Assay Kit (Diazo Method). The decision for this recall stems from the discovery of a new endogenous interference. This interference occurs when a substance inherent to the sample directly reacts with the detection system of the assay, potentially compromising the accuracy and reliability of test results produced by these kits. A Class II recall indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Roche Diagnostics is providing comprehensive details regarding the specific product models, specifications, and batch numbers involved in an attached "Medical Device Recall Event Report Form," enabling healthcare providers and laboratories to identify and remove the affected products from use. This measure underscores the company's commitment to maintaining high standards of product efficacy and patient safety.