China NMPA Product Recall - Albumin Gen.2 (ALB2) Assay Kit (Colorimetric Method); Complement C4 Assay Kit (Immunoturbidimetric Method)

Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall for multiple batches of its Albumin Assay Kit (Colorimetric Method) and Complement C4 Detection Kit (Immunoturbidimetric Assay). This action, reported to the National Medical Products Administration (NMPA) and the Shanghai Drug Administration, stems from confirmed customer complaints and internal investigations into product quality. Initially, on October 18, 2019, Roche reported low quality control recoveries for albumin assay kit batch 33962301 and total bilirubin assay kit batch 36133801. These issues, specific to the cobas c701/702 platforms, exceeded acceptable laboratory limits. While that initial recall concluded by July 20, 2020, subsequent investigations identified another affected albumin batch, 37437301. More recently, new customer complaints confirmed issues with additional batches of the Albumin Assay Kit (43031001, 43718901) and the Complement C4 Detection Kit (36870301). The current voluntary recall is being undertaken to address these quality control deficiencies, ensuring product reliability and adherence to regulatory standards.