# China NMPA Product Recall - Quality control products for fully automated biochemical analyzers

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/ec559726-ca6b-469b-8bae-f40cae76259f/
Source feed: China

> China NMPA product recall for Quality control products for fully automated biochemical analyzers by Ortho-Clinical Diagnostics, Inc. published April 07, 2020. Recall level: Level 3 Recall. On April 7, 2020, the National Medical Products Administration (NMPA) disclosed a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. (USA) is voluntarily recalling quality control products for its fully automated biochemical analyzers.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2020-04-07
- Product Name: Quality control products for fully automated biochemical analyzers
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with incorrect average range (ROM) for specific models and batches.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: On April 7, 2020, the National Medical Products Administration (NMPA) disclosed a voluntary Class III recall initiated by Ortho-Clinical Diagnostics, Inc. The recall involves specific quality control products utilized with fully automated biochemical analyzers. Ortho-Clinical Diagnostics, Inc., the manufacturer, identified that a particular model and batch of these quality control materials contained an incorrect mean range (ROM). This deviation in the expected mean range poses a potential concern for the accuracy and reliability of diagnostic results derived from the biochemical analyzers, as quality control products are essential for ensuring the precision and validity of testing procedures. The company proactively reported this deviation and subsequently launched the voluntary recall to address the issue. A Class III recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. This regulatory action by Ortho-Clinical Diagnostics, Inc., under the oversight of the NMPA, underscores the importance of maintaining high standards for medical diagnostic tools to ensure patient safety and dependable healthcare outcomes. Comprehensive details regarding the affected product models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form" associated with this announcement.

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