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

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/419120f4-fff8-43e7-a4cf-2ad30200b2a4/
Source feed: China

> China NMPA product recall for Immunoglobulin A Detection Kit (Immunoturbidimetric Assay) Tina-quant IgA Gen.2 (IGA-2) by Roche Diagnostics Products (Shanghai) Co., Ltd. published June 13, 2019. Recall level: Level 2 Recall. On June 13, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. proactively initiated a voluntary 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Tina-quant IgA Gen.2 (IGA-2) immunoglobulin A detection kit (immunoturbidimetric assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-06-13
- Product Name: Immunoglobulin A Detection Kit (Immunoturbidimetric Assay) Tina-quant IgA Gen.2 (IGA-2)
- Recall Level: Level 2 Recall
- Recall Reason: Calibration failure and other issues
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/