China NMPA Product Recall - Fully automated blood gas, electrolyte and biochemical analyzer

On April 24, 2015, Roche Diagnostics Products (Shanghai) Co., Ltd., representing Roche Diagnostics GmbH, Germany, initiated a voluntary Class II recall for its Fully Automated Blood Gas, Electrolyte, and Biochemical Analyzers, specifically the cobas b 123 POC systems. This action, overseen by the National Medical Products Administration (NMPA) under registration number CFDA (Imported) No. 20142404167, addressed a significant product issue identified through customer feedback.

The core problem involved the analyzer's tendency to produce elevated total bilirubin results when testing neonatal blood samples that contained cellular microparticles. A critical concern was that these elevated results could be difficult to detect if total hemoglobin and hematocrit parameters were not measured concurrently. The existing instruction manual (Version 9.0) was found to be deficient, as it did not clearly explain the necessity of these simultaneous parameter measurements for accurate neonatal bilirubin assessment.

In response, Roche committed to several corrective actions. These included issuing notification letters to both current and new users of the affected products, informing them of the incident and necessary operational precautions. Additionally, the company identified the root cause of the anomaly and pledged to revise the product's instruction manual to incorporate explicit instructions and clarifications, thereby enhancing user guidance and safeguarding patient safety.