# China NMPA Product Recall - High-risk human papillomavirus (HPV) detection kit (hybrid capture second-generation method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/qiagen-gaithersburg-inc/58c07f83-03dc-4cc8-bae4-9765b5f30808/
Source feed: China

> China NMPA product recall for High-risk human papillomavirus (HPV) detection kit (hybrid capture second-generation method) by QIAGEN Gaithersburg Inc published September 30, 2016. Recall level: Level III. Qiagen Enterprise Management (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its High

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Qiagen Enterprise Management (Shanghai) Co., Ltd. has initiated a voluntary recall of its high-risk human papillomavirus (HPV) test kits.
- Company Name: QIAGEN Gaithersburg Inc
- Publication Date: 2016-09-30
- Product Name: High-risk human papillomavirus (HPV) detection kit (hybrid capture second-generation method)
- Recall Level: Level III
- Recall Reason: The issue involves a batch of products whose packaging shows a shelf life exceeding 12 months, conflicting with the 12-month shelf life stipulated in the registration certificate. The product labeling does not meet regulatory requirements. This is a simple labeling error and will not affect product quality.
- Discovering Company: Qiagen Enterprise Management (Shanghai) Co., Ltd.
- Manufacturing Company: QIAGEN Gaithersburg Inc
- Summary: Qiagen Enterprise Management (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its High-Risk Human Papillomavirus (HPV) Detection Kits (CFDA Import Registration No. 20123404455) in China, as reported to the National Medical Products Administration (NMPA) on July 2, 2016. The recall was prompted by a labeling discrepancy: product packaging displayed an expiration date exceeding 12 months, which contradicted the 12-month shelf life specified in the product's official registration certificate. This inconsistency rendered the labels non-compliant with Chinese medical device regulations. The company clarified that this issue was a labeling error and did not impact the product's quality, safety, or the validity of previously obtained experimental results. No adverse events related to the affected batches (551012149, 551012215, 551012406, 55109403) were reported. As part of the recall, Qiagen instructed distributors and users to immediately quarantine affected product inventory. Further measures included a second notice for distributors to return all impacted products to the QIAGEN Shanghai warehouse by July 25, 2016, with replenishment of compliant products by July 31, 2016. The total quantity of products sold in China and subject to recall was 1964 boxes, all of which were slated for destruction. This proactive recall ensured adherence to national regulatory standards.

Company: https://www.globalkeysolutions.net/companies/qiagen-gaithersburg-inc/936efddd-1f70-46f1-984e-b386adc6b180/