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

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/f4e31cee-2869-430c-9a53-58b007861cae/
Source feed: China

> China NMPA product recall for Prothrombin Time Test Card (Electrochemical Method) by Roche Diagnostics GmbH published January 18, 2019. Recall level: Level 1 Recall. Roche Diagnostics GmbH, through its agent Roche Diagnostics Products (Shanghai) Co., Ltd., initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH's recall of its prothrombin time test card (electrochemical method) products involves changes to sales volume and corrective action.
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2019-01-18
- Product Name: Prothrombin Time Test Card (Electrochemical Method)
- Recall Level: Level 1 Recall
- Recall Reason: Because the WHO has updated its reference standards, product test results calibrated using the new 2016 version of the WHO reference standard (rTF/16) deviate from those calibrated using the original 2009 version of the WHO reference standard (rTF/09). When the INR value is <4.5, the average deviation is within a reasonable range; at high INR values (>4.5), there is a positive deviation that exceeds the expected range.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-gmbh/2a33a337-c39d-4329-b659-c812f690f94b/