# China NMPA Product Recall - RapID NF Plus System for Identifying Non-Fermenting Gram-Negative Bacteria

Source: https://www.globalkeysolutions.net/records/china_product_recall/remel-inc/e150c20c-7431-465f-ba23-31cfecf701ee/
Source feed: China

> China NMPA product recall for RapID NF Plus System for Identifying Non-Fermenting Gram-Negative Bacteria by Remel, Inc. published September 07, 2022. Recall level: Level 3. Remel Inc., operating under Thermo Fisher Scientific, has commenced a voluntary Class III recall con

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Remel Inc. is voluntarily recalling its RapID NF Plus System strips for identifying non-fermenting Gram-negative bacteria.
- Company Name: Remel, Inc.
- Publication Date: 2022-09-07
- Product Name: RapID NF Plus System for Identifying Non-Fermenting Gram-Negative Bacteria
- Recall Level: Level 3
- Recall Reason: The test strip showed a positive reaction in the NO3 wells, rather than exhibiting the negative reaction required by the product's technical specifications.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Remel, Inc.
- Summary: Remel Inc., operating under Thermo Fisher Scientific, has commenced a voluntary Class III recall concerning its RapID NF Plus System identification strips. This critical action was officially reported by Thermo Fisher Scientific (China) Co., Ltd. on September 7, 2022, under the oversight of the National Medical Products Administration (NMPA) of China. The recall stems from a significant product non-conformity where specific models and batches of the identification strips exhibited an erroneous positive reaction within their NO3 wells. These strips are specifically designed for the accurate identification of non-fermenting Gram-negative bacteria, and technical specifications mandate a negative reaction in the NO3 wells. This deviation from expected performance poses a risk of generating inaccurate diagnostic results, which could potentially compromise patient care and lead to inappropriate treatment decisions. The company's immediate required action is a voluntary recall to mitigate potential risks associated with the defective product. Detailed information regarding the affected models and batch numbers is accessible through the "Medical Device Recall Event Report Form." This proactive measure by Remel Inc. demonstrates adherence to regulatory standards and a commitment to ensuring the reliability and safety of medical diagnostic products within the NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/remel-inc/21b0375a-2142-467d-a8fe-8d1f1cae0398/