# China NMPA Product Recall - Leukocyte differentiation antigen CD4 detection kit (flow cytometry - FITC)

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-and-company/4d0b48d9-4f6f-4646-ac7b-b6e378a2440d
Source feed: China

> China NMPA product recall for Leukocyte differentiation antigen CD4 detection kit (flow cytometry - FITC) by Becton, Dickinson and Company published September 02, 2015. Recall level: Level 3 Recall. BD Medical Devices (Shanghai) Co., Ltd., a division of Becton, Dickinson and Company, initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its CD4 leukocyte differentiation antigen detection kit.
- Company Name: Becton, Dickinson and Company
- Publication Date: 2015-09-02
- Product Name: Leukocyte differentiation antigen CD4 detection kit (flow cytometry - FITC)
- Recall Level: Level 3 Recall
- Recall Reason: The original label on the product bottle contains both English and Spanish. Our company discovered that the Spanish description of the product name on the original bottle label mistakenly printed "CD8" instead of "CD4". Our investigation confirms that the outer packaging label and accompanying instructions are correct, the product itself has no quality issues, and it will not pose any risks to patient safety or diagnostic conclusions.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Becton, Dickinson and Company
- Summary: BD Medical Devices (Shanghai) Co., Ltd., a division of Becton, Dickinson and Company, initiated a voluntary Class III recall of its Leukocyte Differentiation Antigen CD4 Detection Kit (Flow Cytometry - FITC). Reported to the National Medical Products Administration (NMPA) on September 2, 2015, the recall was prompted by a labeling error on the original product bottle. Specifically, the Spanish description of the product name incorrectly stated "CD8" instead of "CD4." The company confirmed that this was a typographical error limited to the bottle label, with the outer packaging and accompanying instructions being accurate. Importantly, the product itself had no quality issues and posed no safety or diagnostic risk to patients. The company reported that 23 affected units, identified by Item Number 340133 and Batch Number 5112711, were imported but remained unsold within China. Consequently, all affected inventory has been sealed and is slated for destruction. As no products were distributed or sold, BD Medical Devices (Shanghai) Co., Ltd. will not be issuing customer letters or recall confirmation forms.

Company: https://www.globalkeysolutions.net/companies/becton-dickinson-and-company/584ebc66-20ed-4c0c-8447-169c00c667fd