China NMPA Product Recall - Sex hormone-binding globulin calibrators, sex hormone-binding globulin control products

On February 28, 2019, the National Medical Products Administration (NMPA) published a recall notice concerning products from Beckman Coulter Trading (China) Co., Ltd. The recall specifically involves the Sex Hormone-Binding Globulin Calibrator (A48618) and Sex Hormone-Binding Globulin Control Product (A48619). The core issue identified was a discrepancy between the product labels, which indicated an 18-month shelf life, and the officially registered shelf life of 12 months for these products within China. Beckman Coulter initiated a voluntary Class III recall of the affected calibrators and control products. The company clarified that, despite this labeling inconsistency, the issue does not affect the actual test results or the performance of the products. This action was taken in accordance with Beckman Coulter's internal quality system requirements for product stability and under the regulatory oversight of the NMPA and the Shanghai Food and Drug Administration. Detailed information regarding affected product models, specifications, and batches is available in a separate Medical Device Recall Event Report Form.