# China NMPA Product Recall - Fully automated chemiluminescence analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanjing-renmai-biotechnology-co-ltd/41c9ba1f-02ff-440c-9620-104c3ea432ed/
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 Recall. Nanjing Renmai Biotechnology Co., Ltd. initiated a voluntary Class 3 medical device recall, formally

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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
- Recall Reason: An employee error resulted in the label being printed incorrectly as "Fully Automated Chemiluminescence Meter" instead of "Fully Automated Chemiluminescence Analyzer," which is inconsistent with the registration certificate name. An investigation revealed that this error affected 88 products; 84 are currently in the distributor's warehouse, and 4 are at the end customer's location. This error does not affect the customer's test results and poses no potential hazard.
- Discovering Company: Nanjing Renmai Biotechnology Co., Ltd.
- Manufacturing Company: Nanjing Renmai Biotechnology Co., Ltd.
- Summary: Nanjing Renmai Biotechnology Co., Ltd. initiated a voluntary Class 3 medical device recall, formally reported on January 19, 2022, and published by the National Medical Products Administration (NMPA) on January 20, 2022. The recall pertains to 88 units of its Fully Automated Chemiluminescence Meter (model MCL60). The primary issue stemmed from an employee operational error during labeling. The product label incorrectly displayed "Fully Automated Chemiluminescence Analyzer" instead of the registered name, "Fully Automated Chemiluminescence Meter," creating an inconsistency with the official registration certificate (Su Medical Device Registration Certificate 20192220337). The company clarified that this labeling discrepancy does not impact the product's performance, test results, or patient safety, indicating no potential for harm. Under the guidance of the provincial drug administration, Nanjing Renmai Biotechnology Co., Ltd. took immediate corrective actions. These included issuing formal recall notices to all affected distributors, who were then mandated to inform their respective customers. Furthermore, the company implemented a direct label correction process for all 88 affected units, encompassing 84 units held in distributor inventory and 4 units already at end-customer sites. This swift response ensured compliance with regulatory requirements and addressed the labeling error effectively.

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