China NMPA Product Recall - DAB staining solution and other products

Ventana Medical Systems, Inc. and Roche Diagnostics GmbH, with local distribution by Roche Diagnostics Products (Shanghai) Co., Ltd., issued a product recall for DAB Staining Solution and other medical devices. The recall, initially announced on September 3, 2018, was reclassified from Level 2 to Level 1 by the US FDA, a decision acknowledged by China's National Medical Products Administration (NMPA) on October 31, 2018. The primary issue identified was insufficient silicone oil in a critical part of the reagent dispenser. This deficiency can lead to leakage or blockage, potentially causing incomplete or absent staining during reactions. Such failures could result in light or blank staining, posing a health risk if appropriate control slides are not used concurrently. While a global complaint rate of 0.29% was noted, Roche Diagnostics China reported no related adverse events. The regulatory framework involved the NMPA overseeing the recall in China, aligning with the US FDA's updated severity classification. Required actions include isolating and destroying affected inventory, notifying distributors to seal their existing stock, and assisting customers with product returns for destruction. The reclassification itself did not introduce new measures beyond the existing recall procedures.