# China NMPA Product Recall - Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, yeast identification cards, Neisseria and Haemophilus identification cards, Gram-negative bacteria drug susceptibility cards, Gram-positive bacteria drug susceptibility cards, Streptococcus pneumoniae drug susceptibility cards, and Gram-negative bacteria drug susceptibility cards.

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-inc/3fab0551-a857-4f5d-8df0-8cf9d97144f7/
Source feed: China

> China NMPA product recall for Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, yeast identification cards, Neisseria and Haemophilus identification cards, Gram-negative bacteria drug susceptibility cards, Gram-positive bacteria drug susceptibility cards, Streptococcus pneumoniae drug susceptibility cards, and Gram-negative bacteria drug susceptibility cards. by bioMerieux, Inc published July 27, 2017. Recall level: Level 2. bioMérieux Diagnostics (Shanghai) Co., Ltd. and its manufacturer bioMerieux, Inc. initiated a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary recall of products including Gram-negative bacteria identification cards.
- Company Name: bioMerieux, Inc
- Publication Date: 2017-07-27
- Product Name: Gram-negative bacteria identification cards, Gram-positive bacteria identification cards, yeast identification cards, Neisseria and Haemophilus identification cards, Gram-negative bacteria drug susceptibility cards, Gram-positive bacteria drug susceptibility cards, Streptococcus pneumoniae drug susceptibility cards, and Gram-negative bacteria drug susceptibility cards.
- Recall Level: Level 2
- Recall Reason: A bioMérieux US investigation found that a small number of newly packaged VITEK2 test cards had damaged inner packaging, allowing moisture to enter. This moisture-sensitive antibiotic could degrade, leading to higher MIC values (resulting in false resistance results) or false negatives in ESBL tests. For identification cards, it might cause false positives, but the likelihood of affecting the final test result is very small.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux, Inc
- Summary: bioMérieux Diagnostics (Shanghai) Co., Ltd. and its manufacturer bioMerieux, Inc. initiated a voluntary Level II recall of various VITEK 2 identification and antimicrobial susceptibility testing cards, as published by the National Medical Products Administration (NMPA) on July 27, 2017, based on a report dated June 8, 2017. The recall was prompted by an internal investigation revealing damaged inner packaging bags in some newly packaged VITEK 2 test cards, allowing moisture ingress. This moisture issue could degrade sensitive antibiotics, potentially leading to higher minimum inhibitory concentration (MIC) values and resulting in false resistance results in susceptibility tests. Additionally, it posed a risk of false negative results in ESBL tests, although an advanced expert system was noted to mitigate this impact. For identification cards, false positive reactions were possible, but with minimal likelihood of affecting overall identification. The recall encompasses 53 batches, totaling 70,450 boxes globally, including 56,190 boxes sold in China. Affected products include various VITEK 2 Gram-Negative, Gram-Positive, Yeast, Neisseria/Haemophilus identification cards, and several antimicrobial susceptibility cards. To address this, bioMérieux committed to emailing affected customers and replacing any damaged cards discovered. No related complaints had been received in mainland China at the time of the report.

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