# China NMPA Product Recall - sheath fluid

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-rad-laboratories-inc/2edbf1b5-9c40-4bf2-b444-1fe53d8ad80e/
Source feed: China

> China NMPA product recall for sheath fluid by Bio-Rad Laboratories, Inc. published March 01, 2017. Recall level: Level III. Bio-Rad Medical Products (Shanghai) Co., Ltd. initiated a Level III voluntary recall in China for it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiates voluntary recall of sheath fluid.
- Company Name: Bio-Rad Laboratories, Inc.
- Publication Date: 2017-03-01
- Product Name: sheath fluid
- Recall Level: Level III
- Recall Reason: Bio-Rad China received a customer complaint that the Chinese label of the sheath fluid reagent kit with batch number AA60077 used an incorrect registration certificate number.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Rad Laboratories, Inc.
- Summary: Bio-Rad Medical Products (Shanghai) Co., Ltd. initiated a Level III voluntary recall in China for its Sheath Fluid product, as reported to the National Medical Products Administration (NMPA) on February 3, 2017. The recall was prompted by the discovery of an incorrect registration certificate number printed on the Chinese labels of the Sheath Fluid reagent kits, specifically batch number AA60077. This issue, which affected 18 boxes imported and sold in China, was identified following customer complaints. Under the regulatory framework of the NMPA (previously CFDA), the company’s required actions included immediately notifying all affected customers and providing them with correct labels for implementation of the necessary label corrections. This proactive measure demonstrates Bio-Rad's commitment to ensuring product compliance and addressing labeling discrepancies in accordance with Chinese medical device regulations.

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