China NMPA Product Recall - D-dimer detection kit (immunoturbidimetric method)

Roche Diagnostics Products (Shanghai) Co., Ltd., representing manufacturer Roche Diagnostics GmbH, Germany, initiated a voluntary Class III recall for its D-Dimer Detection Kit (Immunoturbidimetric Assay). This recall, reported to the National Medical Products Administration (NMPA) on April 28, 2015, stemmed from customer complaints and subsequent investigations revealing a critical product defect. The main issue is that immunoglobulins in patient samples, specifically IgM, can interfere with the kit, causing falsely elevated D-dimer test results. This significant interference, influenced by immunoglobulin concentration and structure, was inadequately described in the product's information leaflet, which only cited gamma globulin interference. The affected products, covered under CFDA (Imported) No. 20142404854, are distributed globally. Despite the low incidence rate of this error (approximately one in 100,000), Roche has taken proactive measures to ensure patient safety. Required actions include: sending comprehensive notification letters to all users, informing them of the situation and necessary precautions; and updating the product information leaflet to include complete details regarding the interference of various immunoglobulin types on D-dimer detection. These steps aim to mitigate potential diagnostic inaccuracies and ensure proper product usage.