China NMPA Product Recall - Multiple quality control products for blood gas, electrolyte and biochemical analysis

On July 30, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific quality control products used in blood gas, electrolyte, and biochemical analysis. This action, reported under the National Medical Products Administration (NMPA) framework, stemmed from an internal discovery by Roche Diagnostics regarding an assembly error during the manufacturing process of these quality control kits. The issue affected a small number of batches, specifically batch number 21492898, with serial numbers SN422787 to SN423207. These products were found to have all test parameters at Level 3 potentially exceeding their designated detection range. Roche Diagnostics highlighted that the affected products are equipped with a quality control lockout mechanism. This safeguard either prevents testing or generates immediate alarms for all parameters, effectively alerting operators to the deviation and thereby eliminating potential medical risks to patients and users. The voluntary recall addresses the identified manufacturing discrepancy in adherence to NMPA regulations.