# China NMPA Product Recall - Electrolyte and lipid composite calibrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/c492a29c-722d-4430-994c-601921175bd5/
Source feed: China

> China NMPA product recall for Electrolyte and lipid composite calibrator by Ortho-Clinical Diagnostics, Inc. published December 30, 2019. Recall level: Level 3 Recall. Ortho-Clinical Diagnostics, Inc. (USA) Co., Ltd. initiated a voluntary Class III recall of its Elect

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its electrolyte and lipid composite calibrators.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2019-12-30
- Product Name: Electrolyte and lipid composite calibrator
- Recall Level: Level 3 Recall
- Recall Reason: Urine results may be negatively biased when calibrating a sodium ion assay dry strip (direct electrode method) with a specific batch of the product's electrolyte and lipid composite calibrator.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ortho-Clinical Diagnostics, Inc. (USA) Co., Ltd. initiated a voluntary Class III recall of its Electrolyte and Lipid Composite Calibrators (Registration Certificate No.: 20152402829), as reported by the National Medical Products Administration (NMPA) on December 30, 2019. This action, categorized as a Level III recall, indicates a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences.

The specific reasons or issues leading to the recall are not detailed in the public announcement but are referenced as being available in an attached "Medical Device Recall Event Report Form," which would contain comprehensive information on affected models, specifications, and batch numbers. This recall was overseen by the NMPA, the regulatory body responsible for medical devices in China, ensuring compliance and public safety within the medical product sector.

As a voluntary recall, the company proactively removed the affected calibrators from distribution. The NMPA's involvement highlights the established regulatory framework designed to monitor medical device safety and ensure manufacturers take appropriate corrective actions when product issues arise. This ensures that medical professionals and patients are protected from potentially compromised diagnostic tools.

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