# China NMPA Product Recall - Antimicrobial susceptibility inoculation culture medium

Source: https://www.globalkeysolutions.net/records/china_product_recall/remel-inc/cc87c95a-73f9-4f63-bf90-2e1423daae89/
Source feed: China

> China NMPA product recall for Antimicrobial susceptibility inoculation culture medium by Remel, Inc. published June 11, 2025. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) has released information concerning a voluntary 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Remel, Inc. is voluntarily recalling its drug-sensitive inoculum.
- Company Name: Remel, Inc.
- Publication Date: 2025-06-11
- Product Name: Antimicrobial susceptibility inoculation culture medium
- Recall Level: Level 3 Recall
- Recall Reason: Affected batches of products may exhibit an atypical dark color, which could cause susceptibility testing plates to fail to read automatically or result in minimum inhibitory concentration (MIC) values exceeding the limit.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Remel, Inc.
- Summary: The National Medical Products Administration (NMPA) has released information concerning a voluntary Class III recall initiated by Remel, Inc. for its antimicrobial susceptibility testing inoculation culture medium. Reported by Thermo Fisher Scientific (China) Co., Ltd., the recall addresses a critical product issue: an atypical dark color observed in affected batches. This color deviation can severely impact diagnostic processes, potentially causing antimicrobial susceptibility testing plates to be unreadable by automated systems, or leading to minimum inhibitory concentration (MIC) results that exceed their expected target values. Remel, Inc. is executing this voluntary recall for the product, which is registered under National Medical Device Registration No. 20140220. Importantly, the specific models and batches of products involved in this recall were not imported into China. Comprehensive details regarding the affected products, including specific models and specifications, are documented in the "Medical Device Recall Event Report Form" provided by Remel Company.

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