# China NMPA Product Recall - Chocolate agar medium (without antibiotics)

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-france-sa/0b18621d-db2d-4f86-8e61-fb63cf5db0a8/
Source feed: China

> China NMPA product recall for Chocolate agar medium (without antibiotics) by bioMérieux France SA published September 04, 2020. Recall level: Level 3 Recall. bioMérieux S.A., in conjunction with its subsidiary bioMérieux Diagnostics Products (Shanghai) Co., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux S.A. (France) is voluntarily recalling chocolate agar medium (without antibiotics).
- Company Name: bioMérieux France SA
- Publication Date: 2020-09-04
- Product Name: Chocolate agar medium (without antibiotics)
- Recall Level: Level 3 Recall
- Recall Reason: False negative results may occur when culturing Staphylococcus and Corynebacterium for specific product models and batches.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMérieux France SA
- Summary: bioMérieux S.A., in conjunction with its subsidiary bioMérieux Diagnostics Products (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its Chocolate Agar Medium (Antibiotic-Free). This action, indexed by the National Medical Products Administration (NMPA) as JGXX-2020-10436 and published on September 4, 2020, addresses a critical product performance concern. The primary issue identified is the potential for the medium to produce false negative results when used for culturing specific bacterial strains, namely Staphylococcus and Corynebacterium. This deficiency affects particular models and batches of the product, which is registered under Certificate No.: 20190903. The presence of false negatives can have significant implications for diagnostic accuracy, potentially leading to incorrect clinical assessments or delayed patient care by failing to detect bacterial presence when it exists. The recall level, Class III, indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, the manufacturer is proactively taking steps to mitigate any potential risks associated with the diagnostic inaccuracy. Further specifics regarding the affected product models, precise specifications, and batch numbers are comprehensively detailed in the accompanying "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for complete information on this voluntary corrective action.

Company: https://www.globalkeysolutions.net/companies/biomerieux-france-sa/50067eb4-a2cd-4ff1-837c-cd009918f4ec/