# China NMPA Product Recall - Attellica IM Analyzer (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Immunoassay System (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Chemistry-Immunoassay System (Fully Automated Chemistry-Immunoassay Analyzer)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/ef0e3080-9884-4259-935c-e429455404b8/
Source feed: China

> China NMPA product recall for Attellica IM Analyzer (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Immunoassay System (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Chemistry-Immunoassay System (Fully Automated Chemistry-Immunoassay Analyzer) by Siemens Healthcare Diagnostics Inc. published October 29, 2020. Recall level: Level 2 Recall. On October 29, 2020, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., in coordination with

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following fully automated chemiluminescence immunoassay analyzers: Attellica IM Analyzer, Attellica Solution Immunoassay System, and Attellica Solution Chemistry-Immunoassay System.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2020-10-29
- Product Name: Attellica IM Analyzer (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Immunoassay System (Fully Automated Chemiluminescence Immunoassay Analyzer); Attellica Solution Chemistry-Immunoassay System (Fully Automated Chemistry-Immunoassay Analyzer)
- Recall Level: Level 2 Recall
- Recall Reason: When a user scans the master curve and test definition QR code of a new batch of reagents, if the test definition version of that reagent is higher than the existing test definition version in the system, some user-defined settings for that item may be reset to their default values. This issue only affects user-defined test definition settings.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: On October 29, 2020, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., in coordination with Siemens Healthcare Diagnostics Inc., initiated a voluntary Level II recall of specific fully automated chemiluminescence immunoassay analyzers. This action was mandated by the National Medical Products Administration (NMPA) through the Shanghai Municipal Drug Administration. The recall pertains to Attellica IM Analyzer, Attellica Solution Immunoassay System, and Attellica Solution Chemistry-Immunoassay System. The core issue identified is a software anomaly: when users scan the QR code for a new batch of reagents, and if the reagent's test definition version is newer than what's currently in the system, certain user-defined test settings for that item may inadvertently revert to their default values. This problem specifically impacts custom settings established by users, potentially affecting the accuracy or consistency of diagnostic results if not addressed. As a corrective measure, Siemens is conducting a voluntary recall of the affected medical devices. The detailed list of affected product models, specifications, and batch numbers is provided in a separate "Medical Device Recall Event Report Form." This recall aims to mitigate potential risks associated with the unintended resetting of user-defined parameters, ensuring the reliability of diagnostic tests performed with these systems.

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