# China NMPA Product Recall - Thyroid-stimulating hormone (TSH) assay kit (ELISA); Free triiodothyronine (TTI) assay kit (ELISA); Thyroxine assay kit (ELISA); Luteinizing hormone (LH) assay kit (ELISA); Follicle-stimulating hormone (FSH) assay kit (ELISA); Prolactin assay kit (ELISA); Ferritin assay kit (ELISA); Alpha-fetoprotein (AFP) assay kit (ELISA); Carbohydrate antigen 125 assay kit (ELISA); Carbohydrate antigen 19-9 assay kit (ELISA); Total prostate-specific antigen (PSA) assay kit (ELISA); Carbohydrate antigen 15-3 assay kit (ELISA); Estradiol assay kit (ELISA); Free prostate-specific antigen (PSA) assay kit (ELISA); Carcinoembryonic antigen (CEA) assay kit (ELISA); Free thyroxine assay kit (ELISA); Testosterone assay kit (ELISA).

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/0ef70c4b-6bdb-442f-a875-0b9ce1a5de37/
Source feed: China

> China NMPA product recall for Thyroid-stimulating hormone (TSH) assay kit (ELISA); Free triiodothyronine (TTI) assay kit (ELISA); Thyroxine assay kit (ELISA); Luteinizing hormone (LH) assay kit (ELISA); Follicle-stimulating hormone (FSH) assay kit (ELISA); Prolactin assay kit (ELISA); Ferritin assay kit (ELISA); Alpha-fetoprotein (AFP) assay kit (ELISA); Carbohydrate antigen 125 assay kit (ELISA); Carbohydrate antigen 19-9 assay kit (ELISA); Total prostate-specific antigen (PSA) assay kit (ELISA); Carbohydrate antigen 15-3 assay kit (ELISA); Estradiol assay kit (ELISA); Free prostate-specific antigen (PSA) assay kit (ELISA); Carcinoembryonic antigen (CEA) assay kit (ELISA); Free thyroxine assay kit (ELISA); Testosterone assay kit (ELISA). by Roche Diagnostics Products (Shanghai) Co., Ltd. published October 29, 2021. Recall level: Level 3 Recall. On October 29, 2021, bioMérieux Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Leve

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following kits: Thyroid Stimulating Hormone Assay Kit (ELISA); Free Triiodothyronine Assay Kit (ELISA); Thyroxine Assay Kit (ELISA); Luteinizing Hormone Assay Kit (ELISA); Follicle-Stimulating Hormone Assay Kit (ELISA); Prolactin Assay Kit (ELISA); Ferritin Assay Kit (ELISA); Alpha-Fetoprotein (AFP) Assay Kit (ELISA); Carbohydrate Antigen 125 Assay Kit (ELISA); Carbohydrate Antigen 19-9 Assay Kit (ELISA); Total Prostate-Specific Antigen Assay Kit (ELISA); Carbohydrate Antigen 15-3 Assay Kit (ELISA); Estradiol Assay Kit (ELISA); Free Prostate-Specific Antigen Assay Kit (ELISA); Carcinoembryonic Antigen (CEA) Assay Kit (ELISA); Free Thyroxine Assay Kit (ELISA); and Testosterone Assay Kit (ELISA).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-10-29
- Product Name: Thyroid-stimulating hormone (TSH) assay kit (ELISA); Free triiodothyronine (TTI) assay kit (ELISA); Thyroxine assay kit (ELISA); Luteinizing hormone (LH) assay kit (ELISA); Follicle-stimulating hormone (FSH) assay kit (ELISA); Prolactin assay kit (ELISA); Ferritin assay kit (ELISA); Alpha-fetoprotein (AFP) assay kit (ELISA); Carbohydrate antigen 125 assay kit (ELISA); Carbohydrate antigen 19-9 assay kit (ELISA); Total prostate-specific antigen (PSA) assay kit (ELISA); Carbohydrate antigen 15-3 assay kit (ELISA); Estradiol assay kit (ELISA); Free prostate-specific antigen (PSA) assay kit (ELISA); Carcinoembryonic antigen (CEA) assay kit (ELISA); Free thyroxine assay kit (ELISA); Testosterone assay kit (ELISA).
- Recall Level: Level 3 Recall
- Recall Reason: The product in question is due to several recent complaints received by bioMérieux France regarding substrate errors in their VIDAS reagents. When used with a VIDAS instrument, the VIDAS reagents terminate the test during self-test if a substrate error occurs, thus preventing erroneous results. However, this does create a potential risk of delayed results due to the need for users to replace reagent strips and retest, but it does not pose a medical risk.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On October 29, 2021, bioMérieux Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall for a wide range of its in-vitro diagnostic kits, including Thyroid Stimulating Hormone Assay, Free Triiodothyronine Assay, and various other hormone and antigen detection kits (ELISA/ELISA-linked fluorescence assays). The recall stems from multiple complaints received by bioMérieux France S.A. concerning "substrate errors" in VIDAS reagents. While these errors cause tests to terminate and prevent incorrect results, users may experience delays due to the need for retesting with new strips. The company has clarified that this issue does not pose a direct medical impact. Operating under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, bioMérieux headquarters is actively conducting a root cause investigation and implementing comprehensive corrective and preventative actions to address the underlying problem.

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