China NMPA Product Recall - Immunoglobulin A Detection Kit (Immunoturbidimetric Assay) Tina-quant IgA Gen.2 (IGA-2)

On June 13, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. proactively initiated a voluntary Class II recall for its Immunoglobulin A Detection Kit (Immunoturbidimetric Assay) Tina-quant IgA Gen.2 (IGA-2). This significant regulatory action was formally reported to the Shanghai Food and Drug Administration and falls under the oversight of the National Medical Products Administration (NMPA), China's primary medical product regulatory body. The primary reason for this recall stemmed from identified issues related to calibration failures, which could potentially compromise the accuracy and reliability of diagnostic results obtained from the kit. The affected product, registered under Certificate No. 20162404460, is crucial for accurate immunoglobulin A detection, making precise calibration paramount for patient care. A Class II recall signifies that the product might cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company has made available a "Medical Device Recall Event Report Form" containing comprehensive details on specific affected product models, specifications, and batch numbers. This voluntary recall underscores the company's commitment to product quality and patient safety, aligning with established regulatory frameworks for medical device vigilance and post-market surveillance in China.