# China NMPA Product Recall - Yeast Identification Kit (Colorimetric Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/b6c50655-07fe-4b6a-a5e3-7613c204bfbd
Source feed: China

> China NMPA product recall for Yeast Identification Kit (Colorimetric Method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published December 30, 2021. Recall level: Level 3. BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Yeast Iden

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its yeast identification kit (colorimetric method).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-12-30
- Product Name: Yeast Identification Kit (Colorimetric Method)
- Recall Level: Level 3
- Recall Reason: In some batches of products, the reagent strips were poorly formed, with the thermoplastic molding resulting in a "microcup" shape. This could lead to incorrect identification or no identification results, posing a risk of failing to provide timely guidance for correct antibiotic treatment.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Yeast Identification Kit (Colorimetric Method) on December 30, 2021. This action was taken due to a manufacturing defect where less than 30 reagent strips in specific product batches exhibited "microcup-shaped" thermoplastic molding instead of the required "cylindrical" form. This flaw presents a critical issue, potentially leading to incorrect or no identification results, which could cause delays in reporting and hinder the timely provision of guidance for appropriate antibiotic treatment. As of the recall date, BioMérieux Diagnostics confirmed that no related complaints had been received in mainland China. The recall, overseen by the National Medical Products Administration (NMPA), requires BioMérieux to address this product deficiency. Further details regarding affected product models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form, highlighting the company's commitment to product quality and patient safety within the regulatory framework.

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