# China NMPA Product Recall - Fully Automated Enzyme Immunoassay System

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-rad-laboratories-inc/acdab506-ad8f-40ef-8f10-e6d03a246d11/
Source feed: China

> China NMPA product recall for Fully Automated Enzyme Immunoassay System by Bio-Rad Laboratories, Inc. published February 21, 2017. Recall level: Class III Recall. Bio-Rad Life Sciences (Shanghai) Co., Ltd., on behalf of its manufacturer Bio-Rad Laboratories, Inc.

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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: 2017-02-21
- Product Name: Fully Automated Enzyme Immunoassay System
- Recall Level: Class III Recall
- Recall Reason: The company discovered that an error pattern might occur during product use, leading to invalid test results. Upon receiving customer complaints, the Evolis instrument's system experienced a depletion of washing buffer when processing microplates. The instrument would pause and allow access to the drawer, but the transfer of the microplate might continue until it reached its intended destination. At this point, the bottom drawer must be carefully opened.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Rad Laboratories, Inc.
- Summary: Bio-Rad Life Sciences (Shanghai) Co., Ltd., on behalf of its manufacturer Bio-Rad Laboratories, Inc., initiated a voluntary Level III recall for its "Fully Automated Enzyme Immunoassay (ELISA) System," specifically the EVOLIS instrument (P/N89601). The recall was reported on February 3, 2017, and publicly announced by the National Medical Products Administration (NMPA) on February 21, 2017.

The primary issue identified involved system malfunctions during operation, potentially leading to invalid test results. Customer complaints detailed instances where buffer depletion caused the instrument to pause, necessitating careful manual intervention during microplate transfer. This defect impacted the reliability and accuracy of diagnostic procedures.

Operating under the regulatory oversight of the NMPA, referencing CFDA Imported registration number 20123404090, the recall affects 43 units that were imported and sold in China. To address these concerns and enhance user safety, Bio-Rad is implementing several corrective actions. These include directly notifying affected customers and distributors, affixing new warning labels to the instruments, updating relevant warning statements in the instruction manuals, and revising the system's software. These measures aim to resolve the identified performance and safety issues.

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