China NMPA Product Recall - Creatine kinase isoenzyme assay kit (immunosuppression method)

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level III recall for its Creatine Kinase Isoenzyme Assay Kit (Immunoinhibition Method), specifically catalog number OSR61155. This action, reported to the Jiangsu Provincial Drug Administration under the National Medical Products Administration (NMPA) framework, stems from internal interference testing findings published on May 19, 2021. The company discovered that the CK-MB kit failed to consistently meet the specified lipemia interference performance described in its Instructions for Use (IFU).

The primary issue identified was that the kit did not achieve the stated "interference less than 20% at concentrations up to 900 mg/L" under certain lipemic conditions. While this deviation was noted, Beckman Coulter assessed the associated risk as "very low." The recall does not involve discontinuing the product. Instead, the company is implementing corrective actions, including issuing a Medical Device Recall Notice (FA-000) to inform customers about the updated lipemia interference data. Furthermore, Beckman Coulter plans to revise the IFU to reflect a modified lipemia interference statement of "interference less than 15%," ensuring accurate product information for users.