# China NMPA Product Recall - Disposable capillary lancets

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/b1985296-8570-4051-8886-a504472438f3/
Source feed: China

> China NMPA product recall for Disposable capillary lancets by Roche Diagnostics Products (Shanghai) Co., Ltd. published January 21, 2022. Recall level: Level 3. On January 21, 2022, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling single-use capillary blood collection needles.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2022-01-21
- Product Name: Disposable capillary lancets
- Recall Level: Level 3
- Recall Reason: The time between the expiration date and production date on the English label of some batches of disposable capillary blood collection needles differs from the information regarding the expiration date in the Chinese instructions: "【Storage conditions and shelf life】Store at room temperature, 4 years".
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On January 21, 2022, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its single-use peripheral blood collection needles. This significant action, overseen by the National Medical Products Administration (NMPA) and reported through the Shanghai Municipal Drug Administration, addresses a critical labeling inconsistency. The primary issue identified was a discrepancy between the expiration and production dates printed on the English labels of certain products and the definitive four-year expiration date stated in the corresponding Chinese instructions. Such an error could potentially lead to confusion among healthcare professionals regarding the actual shelf-life and usability of the medical devices, posing a risk to patient safety and the product's intended performance. The company proactively reported this issue and commenced the recall to ensure full compliance with regulatory standards. The affected products are identifiable by Registration Certificate No.: 国械注进20152220495, with comprehensive details on specific models, specifications, and batch numbers provided in the associated "Medical Device Recall Event Report Form." This recall highlights the stringent requirements for accurate labeling in the medical device industry, ensuring transparency and user confidence.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/