# China NMPA Product Recall - Coagulation quality control materials

Source: https://www.globalkeysolutions.net/records/china_product_recall/bio-rad-laboratories-inc/75b2224b-ffb7-418f-b1e7-b93d8421dbd8/
Source feed: China

> China NMPA product recall for Coagulation quality control materials by Bio-Rad Laboratories, Inc. published December 07, 2016. Recall level: Level III. Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bio-Ray Biomedical Products (Shanghai) Co., Ltd. voluntarily recalls coagulation quality control materials.
- Company Name: Bio-Rad Laboratories, Inc.
- Publication Date: 2016-12-07
- Product Name: Coagulation quality control materials
- Recall Level: Level III
- Recall Reason: The coagulation control material, Level 1, may not meet the requirements for storage at 2-25°C after opening as stated in the instructions. Supplementary instructions for opening Level 1 are provided. All other instructions in the instructions for this batch of coagulation control material remain unchanged. The stability statements for Level 2 and Level 3 products remain unchanged.
- Discovering Company: Bio-Ray Life Sciences (Shanghai) Co., Ltd.
- Manufacturing Company: Bio-Rad Laboratories, Inc.
- Summary: Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batches of its Coagulation Quality Control Materials. Formally reported on September 18, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 7, 2016, the recall addresses a critical product stability issue. The primary concern is that Level 1 of the coagulation quality control material may not maintain its stated stability requirements for storage at 2-25 degrees Celsius after opening, conflicting with the product's instructions for use. This affects the material's intended purpose in monitoring the precision of citrate coagulation systems. Affected products include models 744 and 745X, specifically batch number 78421. Bio-Rad confirmed that this instability issue is limited to Level 1, with other instructions and the stability of Level 2 and Level 3 products remaining unaffected. In response, the company has implemented corrective actions. For products currently in stock, a product quality notice will be attached before shipment. For materials already distributed, Bio-Rad is issuing product quality notices and feedback forms to customers through its distributor network. This measure ensures all users are fully informed about the updated storage instructions for Level 1, thereby preventing potential impacts on diagnostic accuracy.

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