China NMPA Product Recall - Prothrombin Time Test Card (Electrochemical Method)

Roche Diagnostics GmbH, through its agent Roche Diagnostics Products (Shanghai) Co., Ltd., initiated a Level 1 voluntary recall of its Prothrombin Time Test Cards (Electrochemical Method) (Registration Certificate No.: 20172400980). This recall, reported to the National Medical Products Administration (NMPA) on December 4, 2018, and updated on January 14, 2019, addresses discrepancies in test results. The core issue arose because the World Health Organization (WHO) updated its reference standards from rTF/09 to rTF/16. Products calibrated with the newer 2016 standard exhibited a positive deviation in Prothrombin Time results when the INR value exceeded 4.5, deviating from results obtained using the original 2009 standard. While deviations for INR values below 4.5 were within an acceptable range, the higher INR discrepancies prompted the recall. In response, Roche Diagnostics implemented several corrective actions. These included notifying distributors and customers of the issue and necessary measures, publishing information on Roche China's official website, and adding a "Letter to Customers" with subsequent product shipments. Crucially, Roche headquarters temporarily recalibrated affected test cards using the original WHO TF/09 standard, with these recalibrated products available since December 2018. Furthermore, the company offers product returns for customers concerned about usability at INR values above 4.5 and plans to supervise the destruction of remaining affected inventory. This recall does not necessitate the complete discontinuation or withdrawal of all affected product batches.