China NMPA Product Recall - Nucleic acid extraction or purification reagents

BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its nucleic acid extraction or purification reagents (Registration Certificate No.: 20180515). This action was announced by the National Medical Products Administration (NMPA) on January 19, 2020, with an update on February 7, 2020. The recall stemmed from an internal investigation by bioMérieux France S.A. following a customer complaint. The primary issue identified was that the pH of an affected product batch was outside the specified range (7.05 instead of 7.1-7.2). This pH imbalance resulted in a colored eluent when the reagents were used to process whole blood or other blood-containing samples. The company's instructions warn that "Colored eluents may inhibit target amplification or affect detection; their use is not recommended," indicating a potential for delayed test results. While the initial complaint originated internationally, BioMérieux Diagnostics (Shanghai) Co., Ltd. confirmed no related complaints within mainland China at the time of the recall. The required action involves the continued voluntary retrieval of the affected products to ensure patient safety and diagnostic reliability.