# China NMPA Product Recall - Attellica CH Analyzer (fully automated biochemical analyzer); Attellica Solution Chemistry System (fully automated biochemical analyzer); Attellica Solution Chemistry-Immunoassay System (fully automated biochemical and immunoassay analyzer)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/a22311e8-3a58-4ffb-b395-fe7c3144fd09/
Source feed: China

> China NMPA product recall for Attellica CH Analyzer (fully automated biochemical analyzer); Attellica Solution Chemistry System (fully automated biochemical analyzer); Attellica Solution Chemistry-Immunoassay System (fully automated biochemical and immunoassay analyzer) by Siemens Healthcare Diagnostics Inc. published November 24, 2021. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. announced a voluntary Level III recall on 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following fully automated biochemical analyzers: Atlica CH Analyzer, Atlica Solution Chemistry System, and Atlica Solution Chemistry-Immunoassay System.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2021-11-24
- Product Name: Attellica CH Analyzer (fully automated biochemical analyzer); Attellica Solution Chemistry System (fully automated biochemical analyzer); Attellica Solution Chemistry-Immunoassay System (fully automated biochemical and immunoassay analyzer)
- Recall Level: Level 3 Recall
- Recall Reason: On Attellica CH 930 fully automated biochemical analyzers with software version v1.25.1 or earlier, issues may arise where the TDef (Test Definition) parameter reverts to its default value and Onboard Stability (OBS) does not update when manually changed when using open-channel assays.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. announced a voluntary Level III recall on November 24, 2021, for several of its Attellica automated biochemical and immunoassay analyzer systems. Affected products include the Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. The recall stems from a software issue in versions v1.25.1 and earlier of the Attellica CH / 930 fully automated biochemical analyzer. Specifically, during open-channel testing, the Test Definition (TDef) parameter has been observed to revert to its default value, and Onboard Stability (OBS) fails to update after manual changes. This malfunction could potentially impact the accuracy and reliability of diagnostic results. The recall is overseen by the National Medical Products Administration (NMPA), China's regulatory authority for medical devices. As a Level III recall, it addresses an issue with a low probability of causing serious health consequences but necessitates corrective action to prevent potential testing inaccuracies. Siemens is providing detailed information on affected product models, specifications, and batch numbers through a "Medical Device Recall Event Report Form" to ensure compliance with regulatory standards and maintain product integrity.

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