China NMPA Product Recall - Urine analysis sheath fluid

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a Level III voluntary recall for its Urine Analysis Sheath Fluid (iQ Lamina), reported by the National Medical Products Administration (NMPA) on June 27, 2022. The recall arose from the discovery that some cartons for the urine analysis sheath fluid had previously been used for iChem Velocity Wash Solution. While product labels attached to the cartons were accurate, the outer cartons occasionally displayed incorrect prior product information.

The main issue is the potential for customers to misidentify and incorrectly use iQ Lamina as iChem Velocity Wash Solution if relying solely on the outer carton. However, Beckman Coulter assessed the likelihood of this error as extremely low and the safety risk as low, primarily because the product caps for iQ Lamina are orange, and those for iChem Velocity Wash Solution are blue, offering clear visual differentiation.

Under NMPA's regulatory framework, Beckman Suzhou is implementing corrective actions by sending