# China NMPA Product Recall - Fully automated chemiluminescence analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanjing-renmai-biotechnology-co-ltd/80cdaa13-eac2-4b50-855b-d1b11715d065/
Source feed: China

> China NMPA product recall for Fully automated chemiluminescence analyzer by Nanjing Renmai Biotechnology Co., Ltd. published January 20, 2022. Recall level: Level 3. Nanjing Renmai Biotechnology Co., Ltd. initiated a voluntary Level 3 recall of 88 units of its MCL60

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanjing Renmai Biotechnology Co., Ltd. voluntarily recalls its fully automated chemiluminescence analyzer.
- Company Name: Nanjing Renmai Biotechnology Co., Ltd.
- Publication Date: 2022-01-20
- Product Name: Fully automated chemiluminescence analyzer
- Recall Level: Level 3
- Recall Reason: An employee made an operational error, printing the label name "fully automated chemiluminescence analyzer" instead of "fully automated chemiluminescence analyzer," which does not match the name on the registration certificate.
- Discovering Company: Nanjing Renmai Biotechnology Co., Ltd.
- Manufacturing Company: Nanjing Renmai Biotechnology Co., Ltd.
- Summary: Nanjing Renmai Biotechnology Co., Ltd. initiated a voluntary Level 3 recall of 88 units of its MCL60 Fully Automated Chemiluminescence Meter, as reported to the National Medical Products Administration (NMPA) on January 19, 2022. The recall stems from an employee operational error, resulting in the product label incorrectly stating "Fully Automated Chemiluminescence Analyzer" instead of the registered name, "Fully Automated Chemiluminescence Meter." This inconsistency with the NMPA registration certificate (Su Medical Device Registration Certificate 20192220337) prompted the recall. The affected devices, designed for qualitative or quantitative detection of various analytes in biological samples, are distributed across China. Crucially, the company confirmed that this labeling error does not impact the accuracy of test results or present any potential harm to users or patients. In response, Nanjing Renmai Biotechnology Co., Ltd. has taken decisive actions. They issued recall notices to all affected distributors, mandating them to inform their respective customers about the incident and necessary steps. Furthermore, the company is implementing label correction measures for all 88 identified units, encompassing both inventory held by distributors and devices already with end customers. This ensures compliance with regulatory standards and rectifies the identified labeling discrepancy.

Company: https://www.globalkeysolutions.net/companies/nanjing-renmai-biotechnology-co-ltd/08ee8a9b-31f3-4e02-8775-ee209e721e29/