# 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).

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/066f8da0-38ae-4a1d-b0c5-3cc7b7f2306d
Source feed: China

> China NMPA product recall for 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). by Roche Diagnostics Products (Shanghai) Co., Ltd. published September 30, 2021. Recall level: Level 2 Recall. On September 30, 2021, bioMérieux Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Cl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following kits: Clostridium difficile toxin A/B assay kit (ELISA); Clostridium difficile glutamate dehydrogenase (GDH) assay kit (ELISA); Human chorionic gonadotropin assay kit (ELISA); Progesterone assay kit (ELISA); Human immunodeficiency virus antigen and antibody assay kit (ELISA); Myoglobin assay kit (ELISA); Procalcitonin assay kit (ELISA); D-dimer Exclusion Test Kit (ELISA) VIDAS D-Dimer Exclusion II (DEX2); N-terminal pro-brain natriuretic peptide assay kit (ELISA); High-sensitivity troponin I assay kit (ELISA).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-09-30
- Product Name: 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).
- Recall Level: Level 2 Recall
- Recall Reason: The product in question has received multiple complaints regarding substrate errors in VIDAS reagents. When VIDAS reagents are used with VIDAS instruments, if a substrate error occurs, the test will be terminated and no incorrect test results will be generated. However, this may lead to a potential risk of delayed test results due to the need for users to replace the reagent strips and retest.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9