China NMPA Product Recall - Chloride ion determination dry film (direct electrode method); Potassium ion determination dry film (direct electrode method)

Ortho-Clinical Diagnostics (China) Co., Ltd. and its U.S. counterpart, Orson Clinical Diagnostics Inc., initiated a voluntary Class II recall of specific batches of their chloride ion and potassium ion determination dry tablets. This recall, officially reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on September 23, 2019, addresses a significant product issue. The primary concern involves intermittent dry tablet distribution problems stemming from the magazine mechanism within certain product lots. This defect has prompted the company to recall the affected medical devices, specifically those identified under Registration Certificate Nos. 20152402858 and 20152402814. The regulatory framework for this action falls under the NMPA, which oversees medical product safety in China, with specific notification via the Shanghai Food and Drug Administration. As a required action, Ortho-Clinical Diagnostics is conducting a voluntary recall to mitigate potential risks associated with the faulty distribution. Further detailed information, including specific product models, specifications, and batch numbers, is available in the "Medical Device Recall Event Report Form," which serves as the comprehensive document for this recall event. This proactive measure ensures compliance with medical device safety standards and protects public health.