China NMPA Product Recall - Fully automated blood typing analyzer

Ortho-Clinical Medical Devices Trading (China) Co., Ltd., in collaboration with Ortho-Clinical Diagnostics, Inc. (UK) Ltd., has initiated a voluntary Class II recall of its fully automated blood typing analyzers (Registration Certificate Nos.: 20173402355; 20173402376). This action, publicly reported by the National Medical Products Administration (NMPA) on March 29, 2021, and the Shanghai Municipal Drug Administration on May 7, 2021, addresses critical performance issues with these medical devices. The primary issues identified involve unreliable liquid level (WLL) checks and the occurrence of negative reactions. These problems specifically arise when users create custom protocols (User-Defined Protocols) and modify the dispensing amounts of reaction components to achieve total expected filling volumes of 50uL, 90uL, or 100uL. Such technical malfunctions could potentially compromise the accuracy and reliability of blood typing results, posing risks to patient diagnostics. Operating under the NMPA's regulatory oversight, the company is undertaking this recall to rectify these product deficiencies and uphold stringent device efficacy and safety standards. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in the accompanying "Medical Device Recall Event Report Form" to guide stakeholders on necessary actions.