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

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.