# China NMPA Product Recall - C-Reactive Protein Assay Kit (Immunoturbidimetric Assay) C-Reactive Protein (CRPL3)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/e7e5ac8e-10f2-4044-88d7-82c7d725e002/
Source feed: China

> China NMPA product recall for C-Reactive Protein Assay Kit (Immunoturbidimetric Assay) C-Reactive Protein (CRPL3) by Roche Diagnostics Products (Shanghai) Co., Ltd. published April 07, 2021. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its C-Reac

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its C-Reactive Protein (CRPL3) assay kit (immunoturbidimetric assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-04-07
- Product Name: C-Reactive Protein Assay Kit (Immunoturbidimetric Assay) C-Reactive Protein (CRPL3)
- Recall Level: Level 3 Recall
- Recall Reason: On the cobas c 311/501 and cobas c 502/701/702 platforms, certain batches of C-reactive protein assay kits exhibited higher imprecision.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its C-Reactive Protein Assay Kit (Immunoturbidimetric Assay) (CRPL3). This action, reported by the Shanghai Municipal Drug Administration on April 7, 2021, falls under the regulatory framework of the National Medical Products Administration (NMPA). The recall was prompted by customer complaints of higher imprecision in certain CRPL3 kit batches, including 541459 and 541462, when used on cobas c 311/501 and cobas c 502/701/702 platforms. Roche Diagnostics confirmed the issue does not affect patient result interpretation or pose medical or health risks. The company has identified the root cause and implemented corrective measures, ensuring that products from batch 541459 and 541462 onwards are no longer affected. The required action is the voluntary recall of the identified non-conforming CRPL3 kits, with further details available in the Medical Device Recall Event Report Form.

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