# 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/fc057ab5-b379-46c1-8c97-7d1101eab690/
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 May 11, 2021. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the following fully automated biochemical analyzers: Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2021-05-11
- 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: When a photometer lamp exceeds its service life, it may increase the intensity of one or more of the 11 wavelengths when used on a fully automated biochemical analyzer. This unpredictable intensity increase can saturate the photometer and may result in erroneous, unlabeled optical test results. An operator event code and alarm will be generated and triggered if the lamp intensity exceeds or falls below the acceptable range for any wavelength.
- 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 Attellica CH Analyzer, Attellica Solution Chemistry System, and Attellica Solution Chemistry-Immunoassay System. This recall, reported via the Shanghai Municipal Drug Administration Website on May 11, 2021, addresses a critical product performance issue. The main problem identified is that when a photometer lamp in these fully automated biochemical analyzers exceeds its service life, it can unpredictably enhance the intensity of one or more of 11 wavelengths. This enhancement may cause the photometer to saturate, potentially leading to erroneous and unmarked optical test results. While an operator event code and alarm are generated if lamp intensity falls outside acceptable ranges, the risk of inaccurate results before such an alarm is a significant concern. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), Siemens Healthcare Diagnostics Inc. is taking proactive steps to mitigate this risk. The required action involves a voluntary recall of affected devices, specified by their registration certificate numbers and detailed in an accompanying Medical Device Recall Event Report Form, aiming to ensure the accuracy and reliability of diagnostic testing.

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