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

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.