# China NMPA Product Recall - Leukocyte differentiation antigen CD2 detection kit (flow cytometry - APC)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-medical-devices-shanghai-co-ltd/40afebaf-277c-4be4-906d-3054680a109c/
Source feed: China

> China NMPA product recall for Leukocyte differentiation antigen CD2 detection kit (flow cytometry - APC) by Smith Medical Devices (Shanghai) Co., Ltd. published March 09, 2019. Recall level: Level 3 Recall. BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Leukocyte Dif

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its Leukocyte Differentiation Antigen CD2 Detection Kit (Flow Cytometry Method - APC).
- Company Name: Smith Medical Devices (Shanghai) Co., Ltd.
- Publication Date: 2019-03-09
- Product Name: Leukocyte differentiation antigen CD2 detection kit (flow cytometry - APC)
- Recall Level: Level 3 Recall
- Recall Reason: The instructions and English label information for the leukocyte differentiation antigen CD2 detection kit need to be corrected.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Smith Medical Devices (Shanghai) Co., Ltd.
- Summary: BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Leukocyte Differentiation Antigen CD2 Detection Kit (Flow Cytometry Method - APC), as reported by the National Medical Products Administration (NMPA) on March 9, 2019. This action was taken due to identified discrepancies requiring corrections to the product's instructions and English labeling information. The recall, indexed under NMPA JGXX-2019-10178 and Shanghai Food and Drug Administration Medical Device Recall 2019-037, specifically targets the kit registered under CFDA (Imported) 2014 No. 3404899. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences. The company's proactive measure addresses the need for accurate and compliant product documentation, ensuring that users receive correct information for safe and effective use. Further details regarding specific models, specifications, and affected batches are available in the accompanying "Medical Device Recall Event Report Form." This recall underscores the regulatory oversight by the NMPA and local authorities in ensuring medical device quality and adherence to labeling standards in China.

Company: https://www.globalkeysolutions.net/companies/smith-medical-devices-shanghai-co-ltd/a4f694b0-5671-4759-922c-b6adb96ecceb/