China NMPA Product Recall - Albumin Gen.2 (ALB2) assay kit (colorimetric method); Complement C4 assay kit (immunoturbidimetric method); Direct bilirubin assay kit (diazo method); C-Reactive Protein (CRPL3) assay kit (immunoturbidimetric method).

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall impacting several in-vitro diagnostic assay kits due to consistent issues with low quality control recoveries. The National Medical Products Administration (NMPA) published this recall notice on December 21, 2020, detailing actions that began earlier in the year.The core problem, identified through customer complaints, involved specific batches of Albumin Gen.2 (ALB2) Assay Kits (Colorimetric) and Total Bilirubin Assay Kits (Diazo Method) exhibiting quality control results below acceptable laboratory limits when used on the cobas c701/702 platform. Subsequent complaint monitoring confirmed similar performance issues with additional batches of Complement C4 Assay Kits (Immunoturbidimetric), and later, Direct Bilirubin Assay Kits (Diazo Method) and C-Reactive Protein Assay Kits (Immunoturbidimetric) (CRPL3). Reagents used on cobas c311/501/502, COBAS INTEGRA 400 plus, and cobas c503 platforms were not affected.Operating under the oversight of the NMPA and the Shanghai Municipal Drug Administration, Roche Diagnostics voluntarily recalled these products. The initial recall for some affected batches was reportedly completed by July 20, 2020, with further batches added to the recall as issues were confirmed. The company was required to remove the identified non-conforming products from distribution to safeguard diagnostic accuracy.