# 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-medical-diagnostics-products-shanghai-co-ltd/07e992af-a108-42a9-87fb-ab84f3fc288a/
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 Medical Diagnostics Products (Shanghai) Co., Ltd. published February 11, 2020. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on 

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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 Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-02-11
- 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 3 Recall
- Recall Reason: The humidity pack (batch number 0010) on the fully automated chemiluminescence immunoassay analyzer malfunctioned, causing the analyzer to disconnect the humidity pack and subsequently suspend the sample processing flow. The humidity pack does not have a batch expiration date; therefore, the system incorrectly identified it as expired.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on February 11, 2020, affecting several fully automated chemiluminescence immunoassay analyzers. The impacted products include the Attellica IM Analyzer, Attellica Solution Immunoassay System, and Attellica Solution Chemistry-Immunoassay System. The primary issue identified was a malfunction in the humidity pack (batch number 0010), which caused the analyzer to detach and suspend the sample processing flow. This malfunction was attributed to the humidity pack lacking a batch expiration date, leading the system to incorrectly flag it as malfunctioning. Under the regulatory framework of the National Medical Products Administration (NMPA), Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is undertaking this voluntary recall to ensure product safety and compliance. The required action involves removing the affected devices from the market, with comprehensive details on specific models and batches provided in a Medical Device Recall Event Report Form. This measure aims to maintain the integrity and reliability of medical diagnostic equipment.

Company: https://www.globalkeysolutions.net/companies/siemens-medical-diagnostics-products-shanghai-co-ltd/deadd648-fc6f-4bb3-90c6-57b16497a6e9/