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

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall, reported on September 6, 2016, for its Fully Automated Blood Gas, Electrolyte, and Biochemical Analyzers (models cobas b 123 <3> POC system and cobas b 123 <4> POC system). This action was taken under the oversight of the National Medical Products Administration (NMPA) of China. The company identified an issue where, in rare instances, testing neonatal blood samples could result in erroneously low bilirubin readings. This malfunction stems from delays or incomplete sample aspiration into the analyzer's measurement chamber, which subsequently affects the analysis software. To address this critical safety concern, Roche Diagnostics is implementing several corrective actions. The company is issuing detailed notification letters to all users, explaining the incident and providing interim guidance to mitigate risks and identify potential erroneous results. The primary long-term solution involves a software upgrade to version 4.8, expected in the fourth quarter of 2016, which will prevent the defect. Upon release, this upgraded software will be installed on all 360 affected units in China (out of 410 globally). It is important to note that this recall focuses on software correction and does not require the physical withdrawal of the medical devices from use. The company has received only two global complaints related to this issue, with none reported in China.