# China NMPA Product Recall - Total protein assay dry slides (colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/649748e9-0bff-42a4-994e-285b40d00421/
Source feed: China

> China NMPA product recall for Total protein assay dry slides (colorimetric method) by Orsendo Medical Equipment Trading (China) Co., Ltd. published December 29, 2020. Recall level: Level 2 Recall. On December 29, 2020, Ausendo Medical Devices Trading (China) Co., Ltd. initiated a Class II volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling total protein assay dry strips (colorimetric method).
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2020-12-29
- Product Name: Total protein assay dry slides (colorimetric method)
- Recall Level: Level 2 Recall
- Recall Reason: Eltrombopag (drug) may interfere with the measurement results of total protein assay dry slides (colorimetric method).
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: On December 29, 2020, Ausendo Medical Devices Trading (China) Co., Ltd. initiated a Class II voluntary recall for its Total Protein Assay Dry Tablets (Colorimetric Method). This action was taken due to a significant safety concern: the potential for eltrombopag, a pharmaceutical drug, to interfere with the accurate measurement results of the assay tablets. The National Medical Products Administration (NMPA) published this recall notice, highlighting the company's proactive measure to address the product's performance issue. The affected product, identified by Registration Certificate No. 国械注进20162404643, is used for total protein measurement. The recall ensures compliance with regulatory standards by removing potentially inaccurate diagnostic tools from circulation. Ausendo's required action is to retrieve the affected batches, as detailed in the 'Medical Device Recall Event Report Form,' thereby mitigating risks to patient health that could arise from incorrect diagnostic results. This voluntary recall underscores the company's commitment to product safety and quality assurance under the NMPA's oversight.

Company: https://www.globalkeysolutions.net/companies/orsendo-medical-equipment-trading-china-co-ltd/9d283785-b2ea-4291-8250-5927daf06726/