# China NMPA Product Recall - Fully automated nucleic acid extraction and purification instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/qiagen-enterprise-management-shanghai-co-ltd/4f3c3948-fd19-4214-9607-cf785479ebd2/
Source feed: China

> China NMPA product recall for Fully automated nucleic acid extraction and purification instrument by Qiagen Enterprise Management (Shanghai) Co., Ltd. published December 06, 2021. Recall level: Level 3 Recall. Qiagen Enterprise Management (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its full

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Qiagen Enterprise Management (Shanghai) Co., Ltd. is voluntarily recalling its fully automated nucleic acid extraction and purification instrument.
- Company Name: Qiagen Enterprise Management (Shanghai) Co., Ltd.
- Publication Date: 2021-12-06
- Product Name: Fully automated nucleic acid extraction and purification instrument
- Recall Level: Level 3 Recall
- Recall Reason: The issue arises because during the "Load tip racks and enzymes" step of the run setup, when users click the Info button for more detailed information, the information provided indicates the minimum volume to be added, not the exact volume stated in Figure 1. If users misunderstand the information in Figure 2 and pipette a volume exceeding the recommended volume stated in Figure 1, the test tube may contain too much or too little reagent. This could lead to over-dilution, under-dilution, or improper lysis of the sample, affecting downstream processing and ultimately resulting in false negative or false positive results.
- Discovering Company: Qiagen Enterprise Management (Shanghai) Co., Ltd.
- Manufacturing Company: Qiagen Enterprise Management (Shanghai) Co., Ltd.
- Summary: Qiagen Enterprise Management (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its fully automated nucleic acid extraction and purification instrument (Registration Certificate No.: 20210494), as reported by the National Medical Products Administration (NMPA) on December 6, 2021. The recall stems from a critical product issue where, during the "Load tip racks and enzymes" step, the instrument's "Info" button displayed inaccurate minimum volume information for reagent addition. This discrepancy between the detailed information and the recommended volume on the operation settings screen could lead users to add incorrect reagent amounts. Consequences include potential over-dilution, under-dilution, or improper sample lysis, significantly affecting downstream processing and posing a risk of false negative or false positive test results. The company's required action is the immediate voluntary recall of affected instruments, with further specifics on models and batch numbers available in the "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential patient safety risks associated with unreliable diagnostic outcomes.

Company: https://www.globalkeysolutions.net/companies/qiagen-enterprise-management-shanghai-co-ltd/489ac37c-0971-4fbe-9255-a3039253ce13/