# China NMPA Product Recall - VITROS Chemistry Products Calibrator Kit 20 (Special Protein Calibrator)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clini-diagnostics-inc-usa/44090e22-de3d-4697-892b-ab7aa9ca5fd9/
Source feed: China

> China NMPA product recall for VITROS Chemistry Products Calibrator Kit 20 (Special Protein Calibrator) by Ortho-Clini Diagnostics, Inc. (USA) published May 22, 2023. Recall level: Level 2 Recall. On May 22, 2023, Ortho-Clinical Diagnostics, Inc. initiated a voluntary Class II recall concerning s

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. (USA) is voluntarily recalling specialty protein calibrators.
- Company Name: Ortho-Clini Diagnostics, Inc. (USA)
- Publication Date: 2023-05-22
- Product Name: VITROS Chemistry Products Calibrator Kit 20 (Special Protein Calibrator)
- Recall Level: Level 2 Recall
- Recall Reason: Specific batches may cause bias in the upper limit of the reportable range.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clini Diagnostics, Inc. (USA)
- Summary: On May 22, 2023, Ortho-Clinical Diagnostics, Inc. initiated a voluntary Class II recall concerning specific batches of its VITROS Chemistry Products Calibrator Kit 20. This medical device, registered under certificate No. 20172400280, is being recalled due to the potential for bias affecting the upper limit of its reportable range. This issue could compromise the accuracy of diagnostic test results derived from these special protein calibrators. The National Medical Products Administration (NMPA) issued notice of this recall, highlighting its role in overseeing medical device safety and quality within the regulatory framework. A Class II recall designation implies that the product's use might lead to temporary or medically reversible adverse health consequences, or that the likelihood of severe health consequences is remote. Ortho-Clinical Diagnostics, Inc. proactively reported this concern and is undertaking the necessary actions to remove the affected products from circulation. This action is critical to uphold product integrity, ensure the reliability of diagnostic data, and ultimately safeguard patient health outcomes. Further comprehensive details, including specific affected product models and specifications, are accessible through the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/ortho-clini-diagnostics-inc-usa/1882e70e-4aa3-4181-8c65-f133f4a168d7/