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

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall of its Carbohydrate Antigen 19-9 Assay Kit (Elecsys CA19-9), as reported on November 29, 2020, by the National Medical Products Administration (NMPA) and Shanghai Drug Administration. This recall updates an earlier report, Shanghai Drug Administration Recall No. 2020-078, addressing performance issues with specific batches of the diagnostic kit.The primary concern involves an increased incidence of "non-reproducible high flyers" when the kit is used on the cobas e 801 platform. This malfunction, identified through customer complaints and internal company investigations, could lead to inaccurate or misleading clinical interpretations for patients. Initially, batch number 416245 was identified, with subsequent investigations revealing that batch 464449 was also affected, albeit to a lesser extent. This updated report additionally identifies batches 483123 and 504743 as impacted. Importantly, the Elecsys CA19-9 test kit remains unaffected when used on cobas e411/e601/e602 platforms. Roche Diagnostics is taking the necessary action to remove the non-compliant products from the market to ensure patient safety and data integrity.