China NMPA Product Recall - Fully automated blood typing analyzer

On July 26, 2019, Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Level II recall for its fully automated blood typing analyzers. This decisive action was taken in response to critical performance concerns, specifically potential malfunctions of the pipetting probe. These malfunctions have been directly attributed to specific software versions, 5.12.3 and 5.12.4, installed on the devices. The recall applies to analyzers covered by registration certificates 20173402355 and 20173402376, underscoring the broad scope of the issue. The recall was reported and overseen by the National Medical Products Administration (NMPA), the primary regulatory body in China responsible for medical device safety and efficacy. While no specific inspection dates were provided in the document, the recall's publication date serves as the official timestamp for this corrective action. The Shanghai Food and Drug Administration also holds a relevant medical device registration certificate, highlighting the multi-agency regulatory context. Ausendo's voluntary measure demonstrates its commitment to addressing product deficiencies and upholding patient safety standards, aligning with the regulatory framework governing medical devices in China. The company's required action involves retrieving the affected units, with comprehensive details on involved models, specifications, and batches available in the accompanying "Medical Device Recall Event Report Form," ensuring thorough resolution of the software-related issue.