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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/c336709c-8817-4231-8dce-a89ca6ab7df8/
Source feed: China

> China NMPA product recall for Sodium ion determination dry plate (direct electrode method) by Ortho-Clinical Diagnostics, Inc. published February 21, 2017. Recall level: . The National Medical Products Administration (NMPA) published a voluntary recall notice on February 

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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: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2017-02-21
- Product Name: Sodium ion determination dry plate (direct electrode method)
- Recall Reason: The company found that measurement results were biased if the products in question were warmed to room temperature for less than 8 hours. For sodium ion assay strips (direct electrode method), warming to 1% to 8 hours before placing them on the analyzer may produce biased results within the 10-day on-board storage period. To ensure acceptable performance of the assay strips within the 10-day on-board storage period, they need to be warmed to room temperature for at least 8 hours.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) published a voluntary recall notice on February 21, 2017, initiated by Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnostics, Inc. The recall involves Sodium Ion Determination Dry Strips (Direct Electrode Method), registered under certificate number 20152402860. The primary issue identified is that the product may yield biased sodium ion measurement results if its rewarming time at room temperature is less than eight hours before being placed on an analyzer. This deviation impacts the product's performance within its 10-day on-board shelf life. A significant quantity of the affected product, 110,756 boxes, was sold in China out of 123,110 boxes imported. Under the NMPA's regulatory oversight, Ortho-Clinical Diagnostics Trading (China) Co., Ltd. has outlined several required actions. These include notifying all affected customers about the issue. Furthermore, customers are instructed to ensure that all unopened refrigerated or frozen dry strips are warmed at room temperature (18-280C/64-820F) for a minimum of eight hours prior to use. Crucially, customers must recalibrate their VITROS analyzers promptly using properly rewarmed strips to prevent biased results, thereby ensuring accurate diagnostic measurements.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/