# China NMPA Product Recall - Sodium ion determination dry slide (direct electrode method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/1ef599b2-c465-45c8-96f9-61edad9c7c8f/
Source feed: China

> China NMPA product recall for Sodium ion determination dry slide (direct electrode method) by Orsendo Medical Equipment Trading (China) Co., Ltd. published February 21, 2017. Recall level: . Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary recall of its Sodium Ion Det

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its sodium ion assay dry strips (direct electrode method).
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2017-02-21
- Product Name: Sodium ion determination dry slide (direct electrode method)
- Recall Reason: If the product in question has been warmed to room temperature for less than 8 hours, the measurement results will be biased.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary recall of its Sodium Ion Determination Dry Strips (Direct Electrode Method), as announced by the National Medical Products Administration (NMPA) on February 21, 2017. The recall was prompted by the company's discovery that the product's measurement results would deviate if the rewarming time at room temperature was less than eight hours. This performance issue raised concerns about the accuracy and reliability of the medical device. As a required action under the NMPA's regulatory framework, Ausendo Medical Devices Trading (China) Co., Ltd. decided to recall the affected products. Detailed information regarding the specific models, specifications, and batches involved in this recall was provided in a "Medical Device Recall Event Report Form," indicating a structured approach to addressing the identified product non-conformity and ensuring patient safety. The company proactively reported the issue and took the necessary steps to remove the potentially flawed products from the market.

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