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

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.