# China NMPA Product Recall - Fully Automated Fluorescence Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomerieux-sa/01a97800-06b3-463b-a805-4c45130af22e/
Source feed: China

> China NMPA product recall for Fully Automated Fluorescence Immunoassay Analyzer by bioMerieux, SA published November 18, 2019. Recall level: Level 2 Recall. bioMerieux S.A., through its subsidiary bioMerieux Diagnostics Products (Shanghai) Co., Ltd., has in

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMerieux S.A. is voluntarily recalling its fully automated fluorescence immunoassay analyzer.
- Company Name: bioMerieux, SA
- Publication Date: 2019-11-18
- Product Name: Fully Automated Fluorescence Immunoassay Analyzer
- Recall Level: Level 2 Recall
- Recall Reason: The issue involves the product software failing to notify the user of the calibration expiration date, leading to the use of expired calibration curves to calculate test results.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: bioMerieux, SA
- Summary: bioMerieux S.A., through its subsidiary bioMerieux Diagnostics Products (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its fully automated fluorescence immunoassay analyzer. This action was prompted by a critical software deficiency where the product failed to alert users about expiring calibration dates. Consequently, the analyzer could continue to process tests using outdated calibration curves, potentially compromising the accuracy of patient test results. The recall, identified by Index No. JGXX-2019-10768 and published by the National Medical Products Administration (NMPA) on November 18, 2019, addresses a significant concern for diagnostic reliability. The NMPA, responsible for overseeing medical device safety and quality in China, serves as the regulatory authority for this recall. bioMerieux is taking corrective measures to mitigate the risk associated with this software flaw, ensuring that healthcare providers can rely on the precise performance of their diagnostic equipment. Specific details regarding affected models, specifications, and batches are contained within the official "Medical Device Recall Event Report Form." This proactive recall underscores the company's commitment to patient safety and adherence to regulatory standards for medical devices.

Company: https://www.globalkeysolutions.net/companies/biomerieux-sa/3062dae8-14a1-439b-b281-c6f0ca786f03/