China NMPA Product Recall - Carbohydrate Antigen 19-9 Assay Kit (Electrochemiluminescence Assay) (Elecsys CA19-9)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall of specific batches of its Carbohydrate Antigen 19-9 Assay Kit (Elecsys CA19-9) for Electrochemiluminescence Imaging. This action, reported to the National Medical Products Administration (NMPA) on April 17, 2020, addresses a significant issue identified with the product. The main problem involves an increase in complaints regarding non-reproducible "high flyers" observed when using batch number 416245 on the cobas e 801 platform. This defect has the potential to adversely affect clinical interpretation. Additionally, an upcoming batch, 464449, was also identified as being affected, albeit with a lower reported incidence rate of the "high flyer" issue. It is important to note that Elecsys CA19-9 test kits utilized on cobas e411, e601, and e602 platforms are not impacted by this problem. The company is taking proactive steps to recall the affected assay kits, identified by Registration Certificate No. 20143405201, to uphold product reliability and patient safety. Further details regarding specific affected models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form."