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

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Fully Automated Blood Gas, Electrolyte, and Biochemical Analyzers, specifically models within the cobas b 123 POC system range. Reported to the National Medical Products Administration (NMPA) on December 7, 2016, the recall addresses a critical issue where the devices may produce erroneously low bilirubin test results when testing neonatal blood samples. This inaccuracy is attributed to a software malfunction that causes delayed or incomplete sample aspiration into the measurement chamber.

To rectify this, Roche Diagnostics is implementing a multi-faceted corrective action plan. The company committed to notifying all affected users with detailed information about the incident and providing interim measures to minimize risks and ensure false negative results are identifiable. The core long-term solution involves a software upgrade to version SW 4.8, anticipated in the fourth quarter of 2016, designed to prevent the aspiration malfunction. This recall, impacting units globally including 188 cobas b 123 <3> POC and 128 cobas b 123 <4> POC systems in China, underscores compliance with NMPA's medical device recall regulations.