# China NMPA Product Recall - Treponema pallidum antibody assay kit (chemiluminescence method) ADVIA Centaur Syphilis (SYPH)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-medical-diagnostics-products-shanghai-co-ltd/c431e7e8-3449-4d1b-a82d-119439640a85/
Source feed: China

> China NMPA product recall for Treponema pallidum antibody assay kit (chemiluminescence method) ADVIA Centaur Syphilis (SYPH) by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. published April 26, 2021. Recall level: Level 3 Recall. Siemens Medical Diagnostics (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its ADVIA Centaur Syphilis (SYPH) Antibody Assay Kit (Chemiluminescence Method).
- Company Name: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-04-26
- Product Name: Treponema pallidum antibody assay kit (chemiluminescence method) ADVIA Centaur Syphilis (SYPH)
- Recall Level: Level 3 Recall
- Recall Reason: Contamination during ADVIA Centaur syphilis testing may affect the results of other tests, causing false positives or negatives. This effect of contamination is only likely to occur if other tests are performed immediately after a syphilis test on the ADVIA Centaur XP/XPT or ADVIA Centaur CP platform.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Siemens Medical Diagnostics (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its Treponema pallidum antibody assay kit, specifically the ADVIA Centaur Syphilis (SYPH) (Registration Certificate No.: 20173406311). This action was announced on April 26, 2021, and published by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall stems from the company's confirmation that contamination originating from the ADVIA Centaur syphilis test may compromise the accuracy of other diagnostic tests. The main issue identified is that this contamination can lead to false increases or decreases in test results for other items, but only if those tests are performed immediately after a syphilis test on the ADVIA Centaur XP/XPT or ADVIA Centaur CP platforms. This specific interaction poses a risk to diagnostic reliability. Siemens Medical Diagnostics (Shanghai) Co., Ltd. is taking this corrective measure to ensure product safety and integrity. Detailed information regarding affected product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form" provided by the company.

Company: https://www.globalkeysolutions.net/companies/siemens-medical-diagnostics-products-shanghai-co-ltd/deadd648-fc6f-4bb3-90c6-57b16497a6e9/