China NMPA Product Recall - Test card

Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its test cards, as officially reported by the National Medical Products Administration (NMPA) on February 22, 2019. The recall stems from critical packaging issues, specifically the incorrect printing of the production date on the outer packaging of the affected medical devices. This manufacturing inaccuracy impacts products registered under CFDA (Imported) No. 20142403270. The recall was processed through the regulatory framework of the Shanghai Food and Drug Administration, indicating a commitment to upholding product quality and patient safety standards. As a required action, Radomet Medical Equipment is withdrawing the implicated test cards from circulation. Further specific details regarding product models, specifications, and batch numbers are accessible within the comprehensive "Medical Device Recall Event Report Form" provided by the NMPA, ensuring transparency and accountability in addressing the identified packaging defect.