China NMPA Product Recall - Quidel Triage® Cardiac Panel (Fluorescent Immunoassay)

Ausendo Medical Devices Trading (China) Co., Ltd. has reported a voluntary Class I recall initiated by its manufacturer, Quidel Cardiovascular Inc. The recall pertains to the Myocardial Injury Test Panel (Fluorescence Immunoassay), also known as the Quidel Triage® Cardiac Panel, registered under National Medical Device Registration Certificate No. 20172402180. The primary reason for this action is the potential for negative bias in troponin results produced by the affected diagnostic product. This issue could lead to inaccurately low readings of troponin levels, which are critical biomarkers for diagnosing myocardial injury. The National Medical Products Administration (NMPA) in China is overseeing this significant recall. A Class I recall designation indicates that there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. While specific inspection dates are not detailed in this announcement, the recall itself is a proactive measure taken by the company. Required actions involve the immediate cessation of use and return of the affected product batches. Comprehensive details regarding the specific models, specifications, and batch numbers subject to this recall are provided in the accompanying "Recall Event Report Form." This proactive measure aims to mitigate potential patient risks associated with inaccurate diagnostic results.