# China NMPA Product Recall - Calcium determination using dry slides (colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/8e9578b6-bd5e-4ce8-bdbc-5af7d8677d5d/
Source feed: China

> China NMPA product recall for Calcium determination using dry slides (colorimetric method) by Orsendo Medical Equipment Trading (China) Co., Ltd. published March 17, 2017. Recall level: . The National Medical Products Administration (NMPA) announced on March 17, 2017, a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its calcium assay dry tablets (colorimetric method).
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2017-03-17
- Product Name: Calcium determination using dry slides (colorimetric method)
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on March 17, 2017, a voluntary Class I recall initiated by Ausendo Medical Devices Trading (China) Co., Ltd. This significant recall pertains to the company's Calcium Assay Dry Tablets (Colorimetric Method), indicating a high potential for serious health consequences. The regulatory framework for this action falls under the NMPA's purview, ensuring compliance within China's medical device sector. While specific defect details for Ausendo's product were not explicitly stated, the recall follows previous issues in the industry. Notably, Dräger Medical Equipment (Shanghai) Co., Ltd. had initiated recall measures in February 2016 for PS500 auxiliary power supplies for ventilators and respiratory therapy systems due to persistent battery defects requiring further improvement. Ausendo's Class I designation suggests a comparable level of concern for patient safety, potentially linking to the broader context of 'related products' mentioned. Ausendo is undertaking this voluntary recall, and detailed information on the affected models, specifications, and batches has been submitted to the NMPA through a "Medical Device Recall Event Report Form," fulfilling regulatory requirements and addressing the identified product issues.

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