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

Roche Diagnostics GmbH, along with its agent Roche Diagnostics Products (Shanghai) Co., Ltd., initiated a voluntary Class I recall for specific batches of its Prothrombin Time Test Cards (Electrochemical Method) (Registration Certificate No.: 20172400980). This action, reported on November 29, 2018, and published by the National Medical Products Administration (NMPA) on December 4, 2018, stemmed from critical test result discrepancies. The core issue was related to an update in the World Health Organization (WHO) reference standard; products calibrated with the 2016 WHO standard (rTF/16) showed positive deviations at high International Normalized Ratio (INR) values (>4.5) compared to those calibrated with the original 2009 standard (rTF/09). This deviation posed a risk of inaccurate patient results, leading the US FDA to classify it as a Level 1 recall, indicating a serious health risk. Roche Diagnostics implemented several corrective measures. These included issuing detailed notification letters to distributors and affected customers, providing standardized recall information templates, and publishing incident specifics on their official website. Additionally, future product shipments will include customer advisory letters. Crucially, Roche Diagnostics headquarters temporarily recalibrated the affected test cards using the original WHO standard rTF/09, while confirming the safety of products calibrated with rTF/16 for INR values between 0.8 and 4.5.