China NMPA Product Recall - Phenylalanine Assay Kit (Fluorescence Method)

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Phenylalanine Assay Kit (Fluorescence Method). This action, publicized by the National Medical Products Administration (NMPA) on May 8, 2017, addressed identified quality control issues affecting specific product batches. The primary concern was an acceptable level of moisture content found in some vials of the Phenylalanine enzyme (lyophilized powder), specifically batch number 651610. This enzyme is a critical component of the assay kit, and the moisture discrepancy could potentially compromise the product's intended quality and performance. The affected finished products are identified under batch number 651865. The company proactively reported this issue to the NMPA, which governs medical device regulations in China. A Class II recall indicates that the product defect could lead to temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled devices were provided in a "Medical Device Recall Event Report Form." This voluntary measure underscores PerkinElmer's dedication to maintaining product safety and adhering to regulatory standards.