# 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/9d9b49f0-2ab1-4b37-895b-4e388698c1d1/
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) reported on October 11, 2017, that bioMérieux Di

---

## 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 with the methods of diluting with agar and micro-dilution 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) reported on October 11, 2017, that bioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Gram-Negative Bacterial Susceptibility Testing Cards. The company identified a significant probability of inaccurate results when using the agar dilution method with these cards, in comparison to the broth microdilution method. This issue directly impacts the reliability of bacterial susceptibility testing. The affected products are identifiable by Registration No.: 20162405211. As a required action, bioMérieux Diagnostics (Shanghai) Co., Ltd. is recalling the implicated batches of these testing cards. Detailed information regarding specific models, specifications, and batch numbers of the affected products is available in the "Medical Device Recall Event Report Form" attachment, which was submitted by the company to the NMPA.

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