# China NMPA Product Recall - Gram-negative bacteria susceptibility testing card VITEK 2 AST-N334

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-sa-france/e3590984-455c-4a27-85d1-989eb67a1faa/
Source feed: China

> China NMPA product recall for Gram-negative bacteria susceptibility testing card VITEK 2 AST-N334 by bioMerieux S.A. (France) published April 25, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMerieux, SA, France, is voluntarily recalling antimicrobial susceptibility testing cards for Gram-negative bacteria.
- Company Name: bioMerieux S.A. (France)
- Publication Date: 2024-04-25
- Product Name: Gram-negative bacteria susceptibility testing card VITEK 2 AST-N334
- Recall Level: Level 3 Recall
- Recall Reason: The concentration of ceftriaxone (cro02n) in a specific batch of cards was calculated incorrectly.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux S.A. (France)
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by bioMerieux, SA, through its subsidiary bioMérieux Diagnostics Products (Shanghai) Co., Ltd., on April 25, 2024. The recall pertains to a specific batch of VITEK 2 AST-N334 Gram-negative bacterial susceptibility testing cards (National Medical Device Registration Certificate No. 20162405205). The primary issue identified was an error in the calculation of ceftriaxone (cro2n) concentration within these affected cards. This critical error could lead to inaccurate susceptibility test results, potentially impacting patient treatment decisions. The recall follows the regulatory framework of the NMPA, which oversees medical device safety and quality in China. While no specific inspection dates are provided in this recall notice, the action reflects bioMerieux's commitment to product quality and patient safety. Customers are advised to refer to the "Medical Device Notice" and "Medical Device Recall Event Report Form" for detailed information regarding affected product models, specifications, batch numbers, and specific actions required for returning or managing the recalled products. This proactive measure aims to mitigate any potential risks associated with the erroneous testing cards.

Company: https://www.globalkeysolutions.net/companies/biomerieux-sa-france/c3ede5b3-ab7f-4302-8855-4c9f56df778c/