# China NMPA Product Recall - Transport culture medium

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-kemajia-microbial-technology-co-ltd/59b4664f-afee-41bd-9913-01516303c724/
Source feed: China

> China NMPA product recall for Transport culture medium by Shanghai Kemajia Microbial Technology Co., Ltd. published June 02, 2021. Recall level: Level 3 Recall. Shanghai Kemajia Microbial Technology Co., Ltd. initiated a voluntary Class III recall of its transp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Kemajia Microbial Technology Co., Ltd. has voluntarily recalled the culture medium it was transporting.
- Company Name: Shanghai Kemajia Microbial Technology Co., Ltd.
- Publication Date: 2021-06-02
- Product Name: Transport culture medium
- Recall Level: Level 3 Recall
- Recall Reason: The products in question were found to have mold growth at the spiral tip and black flocculent matter in the preservation solution, according to reports from Hangzhou Municipal Hospital of Traditional Chinese Medicine and Hangzhou Dingqiao Hospital.
- Discovering Company: Shanghai Kemajia Microbial Technology Co., Ltd.
- Manufacturing Company: Shanghai Kemajia Microbial Technology Co., Ltd.
- Summary: Shanghai Kemajia Microbial Technology Co., Ltd. initiated a voluntary Class III recall of its transport culture medium (Registration Certificate No.: ". The action, publicized on June 2, 2021, followed reports from Hangzhou Central Hospital and Hangzhou Dingqiao Hospital. These hospitals identified critical quality issues, specifically mold at the spiral end and black flocculent matter in the preservation solution of five virus sampling tubes. This significant product defect prompted the company's recall. The recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Although specific inspection dates are not detailed, the recall announcement marks the company's response to the reported quality control failures. Shanghai Kemajia Microbial Technology Co., Ltd. is required to remove the affected transport culture medium from the market, with detailed product information available in a "Medical Device Recall Event Report Form." This action highlights the company's commitment to addressing product non-conformities and ensuring medical device integrity and patient safety within the established regulatory framework.

Company: https://www.globalkeysolutions.net/companies/shanghai-kemajia-microbial-technology-co-ltd/7848141b-4501-425e-aab2-ed7c3c44ccc4/