China NMPA Product Recall - D-dimer quality control material, whole blood immunosuppressant quality control material, C-peptide quality control material, urine chemistry quality control material

Bio-Rad Biomedical Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall of several medical device quality control materials, as reported to the National Medical Products Administration (NMPA) on May 16, 2016. The affected products include D-Dimer, Whole Blood Immunosuppressant, C-Peptide, and Urine Chemistry Quality Control Materials. The primary issue identified was an incorrect expiration date printed on the Chinese labels. Bio-Rad emphasized that this labeling error does not negatively impact the products' normal use or safety. In response to this non-conformance with labeling requirements under the NMPA's regulatory framework, Bio-Rad has implemented specific corrective actions. For all affected products currently in inventory, shipments are to be halted, and items will undergo label correction before release. For products already distributed to customers, Bio-Rad is coordinating with its distributors to issue formal recall letters, ensuring all parties are informed of the labeling discrepancy and the established resolution. This action aims to maintain product integrity and customer confidence.