# China NMPA Product Recall - Attellica UAS 800 Analyzer - Fully Automated Urine Formulation Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/013e1a3b-13ec-4b82-bd60-46f7e337a8c7/
Source feed: China

> China NMPA product recall for Attellica UAS 800 Analyzer - Fully Automated Urine Formulation Analyzer by Siemens Healthcare Diagnostics Inc. published September 24, 2025. Recall level: Level 3 Recall. Siemens Healthcare Diagnostics Inc. initiated a voluntary Class III recall for its Attellica UAS 800

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthcare Diagnostics Inc. is voluntarily recalling its fully automated urine sediment analyzer.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2025-09-24
- Product Name: Attellica UAS 800 Analyzer - Fully Automated Urine Formulation Analyzer
- Recall Level: Level 3 Recall
- Recall Reason: When using a fully automated urine formed elements analyzer (software version 4.0.510) in conjunction with a CLINITEK Novus fully automated dry chemistry urine analyzer, and with custom rules enabled, an error occurs in the application of user-defined rules during blood testing.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Healthcare Diagnostics Inc. initiated a voluntary Class III recall for its Attellica UAS 800 fully automated urine sediment analysis system. This action was reported by Siemens Healthcare Diagnostics Products (Shanghai) Co., Ltd. on September 24, 2025, under the oversight of the National Medical Products Administration (NMPA).

The recall addresses a critical issue identified with the Attellica UAS 800 analyzer, specifically when operating with software version 4.0.510 in conjunction with the CLINITEK Novus fully automated dry chemistry urine analyzer. The main violation involves potential errors in the application of user-defined rules during blood tests, which occur when these rules are enabled within the system. This malfunction could lead to inaccurate test results if not addressed.

As a voluntary recall, Siemens Healthcare Diagnostics Inc. is taking proactive measures to resolve this issue. The Class III designation indicates that while the product violation exists, its use or exposure is not likely to cause adverse health consequences. It is important to note that the specific products involved in this recall were not imported into China, limiting its geographic impact to other regions. Further details on models and specifications are available in the "Medical Device Recall Event Report Form."

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