China NMPA Product Recall - ORTHO VISION Fully Automated Blood Typing Analyzer, ORTHO VISION Max Fully Automated Blood Typing Analyzer

On December 29, 2020, ORTHO Medical Devices Trading (China) Co., Ltd. initiated a Class II voluntary recall for its ORTHO VISION and Max fully automated blood typing analyzers. This action, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Drug Administration, addresses a critical software malfunction. The issue, present in software versions 5.12.8 or 5.13.0, causes inappropriate pipette flushing. This can occur when the pipette arm exits sleep mode, during the loading of reagent or diluent vials, or if an operator accesses maintenance mode before the analyzer completes its reagent inventory. This defect compromises the analyzer's operational integrity. As a required action, the company has voluntarily recalled the affected medical devices, specifically those under Registration Certificate Nos.: 20173402355 and 20173402376. Further details on specific models, specifications, and batches are provided in the accompanying "Medical Device Recall Event Report Form."