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

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/85d9d2ca-6173-4414-9845-951676cdbfcd/
Source feed: China

> China NMPA product recall for Substrate solutions for fully automated immunoassay systems by Siemens Healthcare Diagnostics Inc. published July 19, 2017. Recall level: Level 3. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall for

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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: 2017-07-19
- Product Name: Substrate solutions for fully automated immunoassay systems
- Recall Level: Level 3
- Recall Reason: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. discovered that the production date printed on the label of batch 940853 of the substrate solution for the fully automated epidemic testing system was incorrect (the production date was actually December 8, 2015). The correct production date is December 8, 2016. Based on the correct production date, the product registration information in the product label and instruction manual also needs to be modified 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 Class III voluntary recall for its Substrate Solution for Automated Immunoassay Systems (Medical Device Registration No. 20160545). This action, reported to the National Medical Products Administration (NMPA) on June 6, 2017, and publicly announced on July 19, 2017, addresses a critical labeling error. The recall specifically impacts batch number 940853, encompassing 5000 test kits distributed across China. The core issue stemmed from an incorrect production date printed on the product labels. The labels erroneously displayed December 8, 2015, when the correct production date was December 8, 2016. This inaccuracy also required subsequent modifications to the product's registration information within both the label and the instruction manual to ensure full regulatory compliance. Under the NMPA's regulatory guidance, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is undertaking a series of corrective measures. These include the immediate notification of all affected customers, the replacement of all implicated products, and the reporting of both company inventory and the recalled items to the relevant bureau for supervised destruction. These steps are designed to rectify the labeling discrepancy and maintain product integrity within the medical device supply chain.

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