China NMPA Product Recall - Unsaturated iron binding force determination kit (Nitroso-PSAP method) UIBC

Beckman Coulter, Inc. has initiated a voluntary Class III recall of its Unsaturated Iron Binding Power Assay Kit (Nitroso-PSAP Method) UIBC, as reported by Beckman Coulter Trading (China) Co., Ltd. to the National Medical Products Administration (NMPA) on February 29, 2024. The primary issue identified pertains to an inconsistency between the expiration date of a critical reagent component within a specific kit batch and the overall expiration date displayed for the complete kit. This discrepancy affects the product registered under National Medical Device Registration Certificate No. 20142405086. This action falls under the regulatory oversight of the NMPA, to which the recall event report form and detailed information on affected products and batches have been submitted. While specific inspection dates are not detailed in the provided document, the recall itself serves as the required action, prompted by the identified product non-conformance. Beckman Coulter is proactively managing this situation to ensure product integrity and patient safety by withdrawing the affected kits from circulation, with the Class III designation indicating that the product defect is unlikely to cause adverse health consequences.