MAQUET CRITICAL CARE AB Initiates Voluntary Recall of Anesthesia Machines

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to an internal investigation, it was found that two gaskets on the back cover of the anesthesia machine were improperly placed. The manufacturer, Maquet Critical Care AB, voluntarily recalled its Anesthesia System (Registration No.: Guo Med Reg In 20223080583). The recall level is Class II. 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."　　

Beckman Coulter, Inc. (USA) Voluntarily Recalls Thyroglobulin Antibody Assay Kit

Beckman Coulter Commercial Enterprise (China) Co., Ltd. reported that due to the accidental deletion of the biotin interference statement in the English version of the user manual for the Thyroglobulin Antibody Assay Kit, the manufacturer Beckman Coulter, Inc. voluntarily recalled its Thyroglobulin Antibody Assay Kit (Chemiluminescent Method) Access Thyroglobulin Antibody II (Registration No.: GuoXieZhuJin 20162404041). 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."

Immunotech SAS, A Beckman Coulter Company Voluntarily Recalls Thyroid-Stimulating Hormone Assay Kits

Immunotech SAS, A Beckman Coulter Company, has reported that the use of certain batches of thyroid-stimulating hormone (TSH) assay kits on the DxI 9000 Fully Automated Chemiluminescence Immunoassay Analyzer may produce erroneous results. As a result, the manufacturer, Immunotech SAS, is voluntarily recalling its Access TSH (3rd IS) (Chemiluminescence Method) (Registration No.: GuoXieZhuJin 20182400368). The recall is classified as a Level 2 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.

Synthes GmbH Initiates Voluntary Recall of Trauma Surgical Instrument Kits

Johnson & Johnson Medical (Shanghai) Co., Ltd. reported that due to the front-end width and curvature of the bone retractor product with batch number J010719 being larger than expected, the manufacturer Synthes GmbH has voluntarily recalled its Instruments for Trauma Surgery (Registration No. 20180944). 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 Report Form."

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