# China NMPA Product Recall - Substrate solutions for fully automated immunoassay systems

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/059e012f-d83c-4fd3-bb9d-4260320358a8/
Source feed: China

> China NMPA product recall for Substrate solutions for fully automated immunoassay systems by Siemens Healthcare Diagnostics Inc. published July 18, 2017. Recall level: Level 3. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling substrate solutions for its fully automated immunoassay testing systems.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2017-07-18
- Product Name: Substrate solutions for fully automated immunoassay systems
- Recall Level: Level 3
- Recall Reason: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. discovered an error in the production date printed on the label of batch 940853 of the substrate solution for its fully automated immunoassay system (the incorrect production date was December 8, 2015). The correct production date is December 8, 2016. Based on the correct production date, the product registration information on the product label and instruction manual also needs to be corrected accordingly.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Substrate Solution for Automated Immunoassay Systems (Medical Device Registration No. 20160545), as reported on July 18, 2017. The recall stemmed from a critical labeling error on product batch 940853, impacting 2000 units in China. The labels incorrectly displayed the production date as December 8, 2015, instead of the correct date, December 8, 2016. This discrepancy also necessitated corresponding updates to the product's registration information within the label and instruction manual. Under the regulatory oversight of the National Medical Products Administration (NMPA), the company implemented several corrective actions. Siemens was required to promptly inform all affected customers through formal letters. Furthermore, the company committed to replacing all identified affected products. All recalled units, along with existing company inventory of the erroneous batch, were slated for supervised destruction in coordination with the regulatory authorities. This recall highlights the importance of precise labeling and adherence to product registration details within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/