China NMPA Product Recall - Fully automated biochemical analyzer

The National Medical Products Administration (NMPA) announced a recall for fully automated biochemical analyzers manufactured by Hitachi High-Tech Co., Ltd. and distributed in China by Hitachi High-Tech (Shanghai) International Trading Co., Ltd. Beijing Branch. This recall, reported on September 16, 2011, and published on October 8, 2011, impacts 13 LABOSPECT008 units sold within China. The central issue identified was an abnormal descent of the reagent dispensing mechanism into the cleaning tank. This malfunction occurred when the instrument's power was disconnected or during manual cleaning operations, attributable to the mechanism's own weight. Investigation revealed the root cause to be the protective tape on the electromagnetic braking mechanism's coil. Over time, heat from the motor caused the tape's adhesive to volatilize, leaving residue that adhered to the movable parts of the braking mechanism, consequently delaying its intended braking action. To address this safety concern, the required corrective action involves replacing the defective motor with an upgraded version. The new motor utilizes an adhesive component engineered to resist degradation and volatilization from motor heat, thereby ensuring proper braking functionality. The NMPA mandated that provincial food and drug administrations strengthen supervision of these products.