China NMPA Product Recall - Flow cytometer reagents

Beckman Coulter Biotechnology (Suzhou) Co., Ltd. initiated a voluntary Level III recall of various flow cytometry reagents, as reported on August 23, 2021. The recall stems from an internal discovery by the company that the production registration certificate number printed on the instruction manuals for these reagents was incorrect, specifically missing the character "械". The company explicitly stated that this labeling discrepancy does not impact the safety or effectiveness of the affected products. The recall involves approximately 102 bottles across 10 sales quantities in China, encompassing a range of flow cytometry detection reagents such as CD10, CD117, CD15, CD13, CD3, CD45, CD8, CD16, CD4, and HLA-DR. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA), with the report disseminated via the Jiangsu Provincial Drug Administration. To address the issue, Beckman Coulter Biotechnology (Suzhou) Co., Ltd. is actively notifying its customers and issuing official recall notices. The primary corrective action involves replacing the instruction manuals that contain the erroneous registration certificate number, ensuring compliance without affecting product performance.