# China NMPA Product Recall - BacT/ALERT FA neutralizing antibiotic aerobic culture flask

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-inc/22add7b9-153a-4894-8fee-b48e9b35cc92/
Source feed: China

> China NMPA product recall for BacT/ALERT FA neutralizing antibiotic aerobic culture flask by bioMerieux, Inc published June 01, 2011. Recall level: . The National Medical Products Administration (NMPA) announced on June 1, 2011, a worldwide voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux, Inc. is recalling BacT/ALERT FA neutralizing antibiotic aerobic culture flasks.
- Company Name: bioMerieux, Inc
- Publication Date: 2011-06-01
- Product Name: BacT/ALERT FA neutralizing antibiotic aerobic culture flask
- Recall Reason: The concentration of activated carbon suspension in the product does not meet the product standard, resulting in insufficient antibiotic adsorption, which may lead to false negative results and prevent patients from receiving timely and correct antibiotic treatment.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux, Inc
- Summary: The National Medical Products Administration (NMPA) announced on June 1, 2011, a worldwide voluntary recall by bioMérieux, Inc. for its BacT/ALERT
FA Neutralizing Antibiotic Aerobic Culture Bottles (Batch No.: 1027481). The recall was initiated by bioMérieux USA on April 12, 2011, due to a critical quality issue: the activated carbon suspension concentration in the product did not meet established standards. This deficiency can lead to insufficient antibiotic adsorption, raising concerns about potential false negative culture results. Such inaccuracies could prevent patients from receiving timely and appropriate medical treatment, highlighting a significant patient safety risk. Under the NMPA's oversight, bioMérieux Diagnostics Products (Shanghai) Co., Ltd. subsequently issued an "Emergency Destruction Notice" on April 19, 2011. Required actions include medical institutions continuing to test existing affected bottles, but mandating confirmation via passage culture for any negative results before reporting. Distributors are instructed to destroy or return all unused affected products, whether in inventory or already shipped to customers. The NMPA also urged regional food and drug administration bureaus to enhance supervision of similar products. As of the report, 675 boxes were imported into China, with 23.31 boxes in use, and no adverse clinical reactions reported from the used batches.

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