China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) issued a notice on June 29, 2011, regarding a voluntary recall initiated by Hitachi High-Tech Co., Ltd. for specific batches of its Hitachi 7600 Series fully automated biochemical analyzers. The recall addresses two software-related performance issues, though the company assessed they do not pose a serious health hazard given that disease diagnosis relies on a comprehensive clinical assessment.

The first issue involves potential sample dilution, occurring when internal communication delays conflict with the solenoid valve’s closing, leading to cleaning water diluting samples. The second issue pertains to incorrect sample identification, where simultaneous barcode reading and re-inspection instructions can delay processing, potentially logging a sample ID to an incorrect position on the sample rack. While two dilution reports were received from Japan, no related incidents were reported by users in China for either issue.

Hitachi High-Tech Co., Ltd., with its Beijing branch as the responsible unit in China, began implementing software modifications for all 417 affected units sold in the country in October 2010. These corrective actions, involving software updates and confirmations taking approximately two hours per unit, are targeted for completion by the end of September 2011. The NMPA has instructed provincial food and drug administrations to enhance their supervision of these medical devices.