Roche Diagnostics GmbH Initiates Voluntary Recall of Creatine Kinase Assay Kit (Colorimetric Method)

Roche Diagnostics Products (Shanghai) Co., Ltd. reported that due to issues such as abnormal calibration signals in some products shipped to the United States, the manufacturer Roche Diagnostics GmbH initiated a voluntary recall of its Creatine Kinase Assay Kit (Colorimetric Method) (Registration Certificate for Imported Medical Devices: 20152403262). The recall level is classified as a Class II recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the "Medical Device Recall Event Report Form."

AB Sciex Pte. Ltd. Initiates Voluntary Recall of Liquid Chromatography-Tandem Mass Spectrometry System

Shanghai AB Sciex Analytical Instrument Trading Co., Ltd. reported that due to rare instances such as solvent leakage at the top of the ion source probe, which could eventually pose health or property risks to customers, the manufacturer AB Sciex Pte. Ltd. has initiated a voluntary recall of its LC-MS/MS System (Registration No.: 20232220176). The recall is classified as a Level 2 Recall. The products involved in this recall were not imported into China. For more details, including specific models, specifications, and batch numbers, please refer to the Medical Device Recall Report.

Medtronic Xomed, Inc. Voluntarily Recalls Neuromonitoring Devices in the United States

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues such as false-negative reactions in some products, the manufacturer, Medtronic Xomed, Inc. of the United States, has voluntarily recalled its NIM Vital Nerve Monitoring System (Registration Certificate No.: GuoXieZhuJin 20233070120). The recall is classified as a Level 1 recall. For detailed information regarding the models, specifications, and batches of the affected products, please refer to the Medical Device Recall Report.

Abbott Medical Initiates Voluntary Recall of Implantable Left Ventricular Assist System

Abbott Medical (Shanghai) Co., Ltd. reported that due to the potential issue of screen film lifting in some pre-sterilized implantable left ventricular assist system controllers, Abbott Medical, the manufacturer, has initiated a voluntary recall of its implantable Left Ventricular Assist System (Registration No. 20243120384). The recall is classified as a Level 2 Recall. The products involved in this recall were not imported into China. For more details such as specific models, specifications, and batch numbers, please refer to the "Medical Device Recall Report Form."

Arthrex, Inc. Initiates Voluntary Recall of Ankle Locking Plate System

Arthrex Medical Devices (Shanghai) Co., Ltd. reported that due to incorrect anodizing and laser marking on some products, the manufacturer Arthrex, Inc. is voluntarily recalling its ankle locking plate system Arthrex Fracture Plates and Screws (Registration No.: 20243130121). The recall level is classified as a Level III recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the Medical Device Recall Report.

Wilson-Cook Medical Incorporated Initiates Voluntary Recall of Esophageal Dilators

Cook (China) Medical Trading Co., Ltd. reported that due to the inconsistency between the model number indicated on the packaging and the actual product model, the manufacturer Wilson-Cook Medical Incorporated initiated a voluntary recall of its Savary-Gilliard Dilators esophageal dilators (Registration Certificate No.: 20152024227). The recall is classified as a Level Three recall. The products involved in this recall were not imported into China. For specific model numbers, specifications, batch numbers, and other detailed information, please refer to the Medical Device Recall Event Report.

Biomet UK Limited Initiates Voluntary Recall of Hip Implants

Zimmer (Shanghai) Medical International Trade Co., Ltd. reported that due to the issue of mixed batches of different models of rotator cuffs, the manufacturer Biomet UK Limited voluntarily recalled its hip joint prosthesis Exceed ABT System (Registration No.: 20183131567). The recall level is a Level III recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the "Medical Device Recall Event Report Form."

▲Source of the article:National Medical Products Administration

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