# China NMPA Product Recall - Adult aerobic culture bottles

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-inc/81897d2c-3eb2-4741-bbfb-2ba600df1b48/
Source feed: China

> China NMPA product recall for Adult aerobic culture bottles by bioMerieux, Inc published April 19, 2013. Recall level: . The National Medical Products Administration (NMPA) announced a voluntary recall initiated by bioMer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BioMerieux Inc. of the United States is recalling adult aerobic incubators.
- Company Name: bioMerieux, Inc
- Publication Date: 2013-04-19
- Product Name: Adult aerobic culture bottles
- Recall Reason: Some of the BACT/ALERT SA culture flasks with batch number 1031866 may have uncured sensors. Uncured sensors may lead to false positive and false negative test results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux, Inc
- Summary: The National Medical Products Administration (NMPA) announced a voluntary recall initiated by bioMerieux.Inc and its subsidiary, bioMerieux Diagnostics Products (Shanghai) Co., Ltd., for specific batches of Adult Aerobic Culture Bottles (BACT/ALERT SA culture bottles, batch number 1031866). This action stems from a critical manufacturing defect involving incompletely cured sensors within the culture bottles. This issue can lead to unreliable diagnostic results, specifically false positive and false negative outcomes when testing for microorganisms in blood and other sterile body fluids, potentially impacting patient care. The company proactively reported this situation to the US Food and Drug Administration (FDA) and submitted its recall report to the NMPA on February 20, 2013. Required actions include notifying all affected agents and end-customers through formal letters and collecting all unused or unsold affected products from both distributors' inventories and customer locations for proper disposal or return to bioMerieux Diagnostics Products (Shanghai) Co., Ltd. This recall aims to ensure the reliability of diagnostic testing and safeguard public health.

Company: https://www.globalkeysolutions.net/companies/biomerieux-inc/959a82a5-bac0-46c6-baac-df80d78204af/