# China NMPA Product Recall - Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, anaerobic bacteria and corynebacteria identification cards, Gram-negative bacteria antimicrobial susceptibility testing cards, Gram-positive bacteria antimicrobial susceptibility testing cards, VITEK 2 AST-GP67 Test Kit, Gram-negative bacteria antimicrobial susceptibility testing cards

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/b6d04070-af76-41e9-b333-572bb021d76b/
Source feed: China

> China NMPA product recall for Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, anaerobic bacteria and corynebacteria identification cards, Gram-negative bacteria antimicrobial susceptibility testing cards, Gram-positive bacteria antimicrobial susceptibility testing cards, VITEK 2 AST-GP67 Test Kit, Gram-negative bacteria antimicrobial susceptibility testing cards by Roche Diagnostics Products (Shanghai) Co., Ltd. published March 05, 2019. Recall level: Level 2 Recall. BioMérieux Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall, as annou

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is proactively recalling its Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, anaerobic bacteria and corynebacteria identification cards, Gram-negative bacteria antimicrobial susceptibility testing cards, Gram-positive bacteria antimicrobial susceptibility testing cards (VITEK 2 AST-GP67 Test Kit), and Gram-negative bacteria antimicrobial susceptibility testing cards.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-03-05
- Product Name: Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, anaerobic bacteria and corynebacteria identification cards, Gram-negative bacteria antimicrobial susceptibility testing cards, Gram-positive bacteria antimicrobial susceptibility testing cards, VITEK 2 AST-GP67 Test Kit, Gram-negative bacteria antimicrobial susceptibility testing cards
- Recall Level: Level 2 Recall
- Recall Reason: The product in question had an issue where the top of the inner packaging bag was not completely sealed.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: BioMérieux Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall, as announced by the National Medical Products Administration (NMPA) on March 5, 2019. This action concerns several of the company's in-vitro diagnostic products, including Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, anaerobic bacteria and corynebacteria identification cards, and both Gram-negative and Gram-positive antimicrobial susceptibility test cards, specifically mentioning the VITEK 2 AST-GP67 Test Kit. These products are associated with multiple registration certificate numbers, such as 20162404836 and 20172400631. The fundamental issue driving this recall is an identified defect: an incomplete seal at the top of the inner packaging bags. This packaging flaw could potentially compromise the sterility and integrity of these diagnostic tools, thereby affecting the reliability of test results. The recall is being overseen by the NMPA, with the Shanghai Food and Drug Administration also involved in the reporting. Comprehensive details regarding the specific models, specifications, and affected batches are available in the official "Medical Device Recall Event Report Form" provided by the NMPA. This voluntary measure reflects the company's commitment to upholding product quality and adhering to regulatory standards.

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