# China NMPA Product Recall - Gram-negative bacteria susceptibility testing cards

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/1bbc56d2-7023-4dd0-a54d-6d5e53a2d6c2/
Source feed: China

> China NMPA product recall for Gram-negative bacteria susceptibility testing cards by Roche Diagnostics Products (Shanghai) Co., Ltd. published October 11, 2017. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on October 11, 2017, that bioMérieux D

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary recall of Gram-negative bacteria susceptibility testing cards.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2017-10-11
- Product Name: Gram-negative bacteria susceptibility testing cards
- Recall Level: Level 2 Recall
- Recall Reason: Compared to dilution with agar and microdilution with broth, the products involved have a relatively high probability of producing erroneous results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on October 11, 2017, that bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its bacterial susceptibility testing cards (Registration No.: 20162405211). The company reported that the affected products demonstrated a relatively high probability of generating erroneous results when compared to established agar dilution and broth microdilution methods. This significant discrepancy in performance posed a risk to accurate diagnostic testing. As a result, bioMérieux Diagnostics (Shanghai) Co., Ltd. proactively took action to withdraw the non-conforming batches from the market. The recall, overseen by the NMPA, highlights the regulatory body's role in ensuring the safety and efficacy of medical devices in China. Further detailed information regarding specific models, specifications, and batch numbers of the recalled products is available in the official "Medical Device Recall Event Report Form" provided by the NMPA.

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