China NMPA Product Recall - Immunosuppressant compound quality control products

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its immunosuppressant complex quality control kits (Registration Certificate No.: 国械注进20152400739) on December 27, 2021. The recall, reported to the National Medical Products Administration (NMPA) and originating from the Shanghai Municipal Drug Administration, was prompted by the discovery that a specific batch (02211200) of these kits, shipped to the Chinese market, lacked essential Chinese instructions. The issue was identified by Abbott's core diagnostics department, highlighting a critical omission in product information required for the local market. The absence of proper Chinese instructions poses a potential risk to users, who may not be able to operate the device correctly or understand important safety information. In response to this compliance issue, Abbott Trading (Shanghai) Co., Ltd. is undertaking the necessary actions to remove the affected products from distribution. This voluntary recall underscores the company's commitment to product safety and adherence to regulatory requirements, ensuring that medical devices supplied to the Chinese market include all necessary localized documentation to safeguard patient and user well-being. The "Medical Device Recall Event Report Form" contains further details regarding the models and specifications involved in this action.