# China NMPA Product Recall - Fully Automated Enzyme Immunoassay System

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-rad-laboratories-inc/619eec13-3827-49ea-bfff-0c7f0ddb1fa7/
Source feed: China

> China NMPA product recall for Fully Automated Enzyme Immunoassay System by Bio-Rad Laboratories, Inc. published March 01, 2017. Recall level: Class III Recall. Bio-Rad Biomedical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of 43 units 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. is voluntarily recalling its fully automated enzyme immunoassay analyzer.
- Company Name: Bio-Rad Laboratories, Inc.
- Publication Date: 2017-03-01
- Product Name: Fully Automated Enzyme Immunoassay System
- Recall Level: Class III Recall
- Recall Reason: The company discovered a potential error pattern during product use that could invalidate test results. Customer complaints indicate that the Evolis instrument system experiences a runaway cleaning buffer issue when processing microplates. The instrument pauses and allows access to the drawer, but plate delivery may continue until it reaches its intended destination. During this process, the bottom drawer must be opened with extreme care. To enhance user safety and protection when using the #P/N89601 (configuration codes 89700 or 89818) Evolis instrument, a proactive recall has been initiated.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Rad Laboratories, Inc.
- Summary: Bio-Rad Biomedical Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of 43 units of its Fully Automated Enzyme Immunoassay (ELISA) System (Evolis, P/N89601) in China, as reported to the National Medical Products Administration (NMPA) on February 3, 2017. The recall stems from customer complaints regarding a specific malfunction where the instrument experiences buffer depletion during microplate processing, causing it to pause and potentially leading to invalid test results. This issue posed a concern for user safety and accurate diagnostic output. Under the NMPA's oversight, Bio-Rad is implementing several corrective actions. These include dispatching notification letters to all affected customers via distributors to inform them of the issue and necessary precautions. Additionally, the company will affix warning labels directly onto the front panels of the recalled instruments and update the instruction manuals to include revised warning statements. Crucially, a software revision will be rolled out to address the underlying cause of the buffer depletion malfunction, aiming to prevent recurrence and restore the system's intended performance and safety.

Company: https://www.globalkeysolutions.net/companies/bio-rad-laboratories-inc/72718e6c-ce5a-4197-9470-fc93a67e62a1/