China NMPA Product Recall - Ultra-high performance liquid chromatography-tandem mass spectrometry system (ACQUITY UPLC I-Class IVD/Xevo TQ-D IVD System; ACQUITY UPLC I-Class IVD/Xevo TQ-S IVD System)

Waters Technology (Shanghai) Co., Ltd. announced a voluntary Level III recall for its Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry Systems (UHPLC-MS/MS) on April 13, 2021. The recall involves specific models, ACQUITY I-S and ACQUITY I-X, which are registered medical devices under the National Medical Products Administration (NMPA). The core issue identified was the absence of a critical system label on these products. An internal review by Waters confirmed that during a label update on February 19, 2020, intended to reflect renewed NMPA medical device registration numbers, the Chinese labels were modified, but the system label was inadvertently missed. This oversight resulted in non-compliance with Chinese regulatory requirements for medical device labeling. Waters Technology (Shanghai) Co., Ltd. is addressing this through corrective actions that do not require the physical return of the products. The primary actions involve correcting and affixing the missing system labels on the affected UHPLC-MS/MS units to ensure full adherence to NMPA regulations, thereby resolving the labeling discrepancy and maintaining regulatory compliance.