China NMPA Product Recall - sheath fluid

Bio-Rad Life Sciences (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Sheath Fluid products, formally reported to the National Medical Products Administration (NMPA) on February 3, 2017, and publicly announced on February 21, 2017. The primary issue identified was a critical labeling error: the Chinese labels for the affected products displayed an incorrect registration certificate number. This recall specifically involved batch number AA60077, encompassing 18 boxes of Sheath Fluid that had been distributed and sold in China. The product itself is vital for flow cytometry applications, where it forms the sheath fluid enabling microspheres to pass individually for precise laser sorting and counting. Upon discovering the discrepancy, Bio-Rad Life Sciences (Shanghai) Co., Ltd. took swift corrective measures. The company promptly notified all affected customers within China about the incorrect labeling. As a resolution, Bio-Rad provided the correct labels directly to these customers, instructing them to implement the necessary label corrections on their existing product inventory. This action underscores the company's commitment to maintaining accurate product information and adhering to the regulatory standards set by the NMPA.