China NMPA Product Recall - Fully Automated Rapid Microbial Mass Spectrometry Detection System

On May 7, 2015, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by BioMerieux Diagnostics (Shanghai) Co., Ltd., on behalf of BioMerieux SA. The recall concerned their Fully Automated Rapid Microbial Mass Spectrometry Detection System. The primary issue identified was a software defect where the continuous accumulation of historical data could cause the device’s data server to slow down. This slowdown, particularly in laboratories with high sample volumes and LIS integration, had the potential to delay the transmission of microbial identification results to the Laboratory Information System. It was noted that the accuracy of the clinical specimen identification results themselves was not compromised.

To address this, the bioMérieux Group implemented a global corrective action plan. Short-term measures involved issuing customer letters, dispatching engineers to clear historical data either remotely or on-site, and releasing a software upgrade package in April 2015 for immediate installation on affected units. For a lasting solution, ongoing software upgrades are being developed, with all new products expected to incorporate the updated software version by April 2016. Additionally, existing inventory could continue to be sold, provided that the required customer letter was issued.