China NMPA Product Recall - ARCHITECT c16000 System/ARCHITECT c4000 System Fully Automated Biochemical Analyzer

Abbott Laboratories, through its entity Abbott Trading (Shanghai) Co., Ltd., announced a voluntary Class III recall for its ARCHITECT c16000 System and ARCHITECT c4000 System automated biochemical analyzers. This action, published on August 10, 2022, falls under the regulatory purview of the National Medical Products Administration (NMPA) in China. The core issue driving this recall stems from an administrative error in product distribution: two specific ARCHITECT c4000 System machines, identified by serial numbers c400033 and c400048, were inadvertently sent to incorrect customers. As a corrective measure, Abbott Laboratories is actively recalling these fully automated biochemical analyzers to rectify the distribution error. The Class III designation for this recall signifies that while the product deviation occurred, the likelihood of serious adverse health consequences is considered low. This proactive step demonstrates the company's commitment to maintaining proper medical device control and adherence to established regulatory frameworks governing product integrity and customer safety. Further comprehensive details regarding the specific affected product models, specifications, and batch numbers are documented within the accompanying "Medical Device Recall Event Report Form," which provides transparency on the scope of the recall.