# China NMPA Product Recall - Whole-segment parathyroid hormone assay kit (chemiluminescence method); Whole-segment parathyroid hormone calibrators

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-tc2016-196/5c45a091-bb2e-4b30-99ae-78baa1de3aa3/
Source feed: China

> China NMPA product recall for Whole-segment parathyroid hormone assay kit (chemiluminescence method); Whole-segment parathyroid hormone calibrators by Ortho-Clinical Diagnostics (TC2016-196) published December 29, 2016. Recall level: Class II Recall. This document from the National Medical Products Administration (NMPA) details a voluntary Class II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its whole-segment parathyroid hormone assay kit (chemiluminescence method) and whole-segment parathyroid hormone calibrators.
- Company Name: Ortho-Clinical Diagnostics (TC2016-196)
- Publication Date: 2016-12-29
- Product Name: Whole-segment parathyroid hormone assay kit (chemiluminescence method); Whole-segment parathyroid hormone calibrators
- Recall Level: Class II Recall
- Recall Reason: The company has become aware of potential bias in its products compared to other available methods through customer complaints, which could affect diagnosis and lead to unnecessary additional (or misleading) treatment. Ortho observed a 40% positive bias when using the VITROS iPTH kit compared to the Roche Elecsys PTH assay kit for samples with iPTH concentrations <100 pg/mL. Due to the limited availability of samples with iPTH concentrations >100 pg/mL, the investigation may require further time.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (TC2016-196)
- Summary: This document from the National Medical Products Administration (NMPA) details a voluntary Class II medical device recall initiated by Ortho-Clinical Diagnostics (China) Co., Ltd., and reported by Ausendo Medical Devices Trading (China) Co., Ltd. The recall, reported on November 7, 2016, and published on December 29, 2016, concerns the Full-Segment Parathyroid Hormone Assay Kit (Chemiluminescence Method) and its associated calibrators. No inspection dates are applicable as this is a voluntary recall.

The primary issue identified through customer complaints was a significant bias in test results. Specifically, the VITROS iPTH kit exhibited a 40% positive bias when measuring iPTH concentrations above 100 pg/mL, in comparison to the Roche Elecsys PTH test kit. This critical discrepancy could negatively impact patient diagnoses and potentially lead to inappropriate or misleading medical treatments.

Operating under the NMPA's medical device regulatory framework, Ortho-Clinical Diagnostics has taken responsibility for recalling all affected batches globally, including those imported into China. The required action for this recall involves the return of the identified products. The company also noted that further investigation into the bias may require additional time due to the scarcity of relevant high-concentration samples, emphasizing the importance of ensuring accurate diagnostic testing.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-tc2016-196/3fce0c14-c724-4647-a932-593127fb93e8/