# China NMPA Product Recall - QIAsymphony DNA Midi Kit (Nucleic Acid Extraction or Purification Reagent)

Source: https://www.globalkeysolutions.net/records/china_product_recall/qiagen-gmbh/f9c3fcd0-9be3-4ed5-b098-591dfad4ed62/
Source feed: China

> China NMPA product recall for QIAsymphony DNA Midi Kit (Nucleic Acid Extraction or Purification Reagent) by QIAGEN GmbH published December 23, 2024. Recall level: Level 3 Recall. QIAGEN GmbH, a medical device manufacturer, has initiated a voluntary Class III recall of its QIAsym

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: QIAGEN GmbH initiates a recall of nucleic acid extraction or purification reagents.
- Company Name: QIAGEN GmbH
- Publication Date: 2024-12-23
- Product Name: QIAsymphony DNA Midi Kit (Nucleic Acid Extraction or Purification Reagent)
- Recall Level: Level 3 Recall
- Recall Reason: Some products have incorrect or missing 2D barcodes.
- Discovering Company: Qiagen Enterprise Management (Shanghai) Co., Ltd.
- Manufacturing Company: QIAGEN GmbH
- Summary: QIAGEN GmbH, a medical device manufacturer, has initiated a voluntary Class III recall of its QIAsymphon DNA Midi Kit (National Medical Device Registration No. 20140004). This action, reported by its subsidiary Qiagen Enterprise Management (Shanghai) Co., Ltd., is in response to product issues involving incorrect or missing two-dimensional barcodes on certain batches. The National Medical Products Administration (NMPA) published this recall information on December 23, 2024. The primary concern is the potential for operational inefficiencies or misidentification due to the barcode discrepancies, although specific inspection dates leading to this discovery are not detailed in the provided document. Importantly, the affected products implicated in this recall were not imported into the Chinese market, limiting the direct impact within China. QIAGEN GmbH is undertaking this recall to ensure product quality and regulatory compliance, following established NMPA guidelines for medical device recalls. Further specifics regarding the models, specifications, and batch numbers involved are available in the "Medical Device Recall List" and the "Medical Device Recall Event Report Form" attachments. The company is committed to addressing the identified issue to maintain product integrity and safety standards.

Company: https://www.globalkeysolutions.net/companies/qiagen-gmbh/995d4052-a248-466a-bfe2-61192b5688df/