# China NMPA Product Recall - Fully automated immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/tosoh-shanghai-biotechnology-co-ltd/74df765e-6128-494d-878a-9abfdcb48167/
Source feed: China

> China NMPA product recall for Fully automated immunoassay analyzer by Tosoh (Shanghai) Biotechnology Co., Ltd. published April 24, 2020. Recall level: Level 2 Recall. Tosoh (Shanghai) Biotechnology Co., Ltd. initiated a voluntary Class II recall for its automated imm

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Tosoh (Shanghai) Biotechnology Co., Ltd. has initiated a voluntary recall of its fully automated immunoassay analyzer.
- Company Name: Tosoh (Shanghai) Biotechnology Co., Ltd.
- Publication Date: 2020-04-24
- Product Name: Fully automated immunoassay analyzer
- Recall Level: Level 2 Recall
- Recall Reason: The issue involves a sensor in the substrate liquid remaining level monitoring unit that is too sensitive, which may prevent the detection of insufficient substrate liquid even when the substrate liquid is depleted.
- Discovering Company: Tosoh (Shanghai) Biotechnology Co., Ltd.
- Manufacturing Company: Tosoh (Shanghai) Biotechnology Co., Ltd.
- Summary: Tosoh (Shanghai) Biotechnology Co., Ltd. initiated a voluntary Class II recall for its automated immunoassay analyzer (Registration Certificate No.: 20153402770). This action, publicized on April 24, 2020, by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration website, addresses a significant product defect. The core issue involves the substrate liquid remaining volume monitoring unit, where the sensor has been identified as being excessively sensitive. This heightened sensitivity can lead to a critical malfunction: the analyzer may fail to register that the substrate liquid supply is depleted, even when it is. Such an oversight could result in tests being performed without adequate reagents, potentially yielding unreliable or erroneous diagnostic results, which is a serious concern for patient care and medical accuracy. In response to this potential risk, Tosoh (Shanghai) Biotechnology Co., Ltd. voluntarily undertook the recall to ensure the safety and efficacy of its medical devices. The company is collaborating with regulatory authorities under the framework of the NMPA to manage this recall effectively. While specific inspection dates were not detailed in this recall notice, the company’s prompt action aligns with regulatory expectations for addressing product non-conformities. Comprehensive information regarding the precise models, specifications, and affected batch numbers for the recalled analyzers is provided in the "Medical Device Recall Report Form," which serves as the official documentation for this event. This voluntary recall underscores the company's commitment to maintaining high standards of product quality and patient safety within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/tosoh-shanghai-biotechnology-co-ltd/e7f001fe-6ec5-419b-bbfd-a156d6e3fb4f/