China NMPA Product Recall - Clostridium difficile toxin A/B assay kit (ELISA); Clostridium difficile glutamate dehydrogenase (GDH) assay kit (ELISA); Human chorionic gonadotropin (hCG) assay kit (ELISA); Progesterone assay kit (ELISA); Human immunodeficiency virus (HIV) antigen and antibody assay kit (ELISA); Myoglobin assay kit (ELISA); Procalcitonin assay kit (ELISA); D-dimer exclusion assay kit (ELISA); VIDAS D-Dimer Exclusion || (DEX2); N-terminal pro-brain natriuretic peptide assay kit (ELISA); High-sensitivity troponin I assay kit (ELISA).

On September 30, 2021, bioMérieux Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of multiple in-vitro diagnostic assay kits. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The affected products encompass various ELISA and enzyme-linked immunofluorescence assay kits, including those for Clostridium difficile toxin A/B, Human chorionic gonadotropin, Human immunodeficiency virus antigen and antibody, and high-sensitivity troponin I. The recall was prompted by multiple complaints concerning 'substrate errors' identified in VIDAS reagents when used with VIDAS instruments. While these errors lead to test termination, preventing potentially erroneous results, they introduce a risk of delayed patient diagnoses as users are required to replace reagent strips and retest. bioMérieux's headquarters is actively conducting a root cause investigation into these issues and has already implemented corrective and preventative actions to address the problem. The voluntary recall aims to mitigate any potential impact on clinical timelines and patient care.