# China NMPA Product Recall - Fully Automated Nucleic Acid Extraction, Purification, and Medical PCR Analysis System

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/7ca1e2d7-e7e8-4f66-ac30-32ac226b8891/
Source feed: China

> China NMPA product recall for Fully Automated Nucleic Acid Extraction, Purification, and Medical PCR Analysis System by Roche Diagnostics Products (Shanghai) Co., Ltd. published July 19, 2019. Recall level: Level 2 Recall. On July 19, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated nucleic acid extraction, purification, and medical PCR analysis system.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-07-19
- Product Name: Fully Automated Nucleic Acid Extraction, Purification, and Medical PCR Analysis System
- Recall Level: Level 2 Recall
- Recall Reason: The processing transport head failed the airtightness check of the separation and purification module, and droplet traces were found on the nucleic acid separation and purification platform, heating station, and separation station. Leakage of the processing transport head may lead to invalid or false positive results.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On July 19, 2019, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its fully automated nucleic acid extraction, purification, and medical PCR analysis system, specifically the cobas 6800/8800 models. This action was prompted by complaints received by Roche Diagnostics headquarters regarding the failure of the processing transport head to pass the airtightness check within the system's separation and purification module. Investigations revealed droplet traces on critical internal components, indicating a leakage issue with the processing transport head. This malfunction carries a significant risk of producing invalid or false positive test results, which could adversely impact diagnostic accuracy. The recall is being managed under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, as evidenced by NMPA Index No. JGXX-2019-10452. The company is undertaking this recall to address the identified product malfunction, safeguard patient outcomes, and ensure the integrity of diagnostic data. Further details regarding affected product models, specifications, and batches are provided in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/