China NMPA Product Recall - D-dimer quality control products

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its D-dimer quality control products (batch number 439398, catalog number 05050936190), as reported on November 16, 2020, by the National Medical Products Administration (NMPA). The recall was prompted by complaints indicating that high-value quality control products were recovering within the concentration range designated for low-value quality control material. Investigation revealed a manufacturing error during the filling process by an external supplier. Specifically, a small quantity of high-value quality control material (Level II, bottle batch 439389, DD2-H, code 243) was mistakenly filled with low-value quality control material. This error affects a total of 68,000 bottles, with an estimated 58 bottles potentially being incorrectly filled. The company asserts that this issue is not expected to impact patient or diagnostic test results, and no medical risk to patients or users can be entirely ruled out. The voluntary recall serves as the primary required action to address this quality control discrepancy, ensuring product integrity within the regulatory framework established by the NMPA. The company is actively managing the recall of the affected D-dimer quality control material (Registration Certificate No.: 20142405155).