China NMPA Product Recall - Polymer separating adhesive POP-6 Polymer/POP-7 Polymer

On September 4, 2019, INGJI (Shanghai) Trading Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, announced a voluntary Class III recall of its Polymer Separating Gel, specifically POP-6 Polymer and POP-7 Polymer. This action was prompted by a critical issue involving the RFID tags incorporated into certain product batches. These defective RFID tags intermittently interfered with the identification process by crucial gene analyzers, including models 3500 Dx and 3500 xL Dx. The company noted that while not every product within the identified batches was experiencing this problem, the potential for intermittent identification failure necessitated the recall to prevent operational disruptions in diagnostic settings. The recall, a proactive measure by INGJI (Shanghai) Trading Co., Ltd., aims to mitigate risks associated with unreliable product identification. Comprehensive details concerning the specific models, specifications, and batch numbers affected by this recall were provided in a supplementary Medical Device Recall Event Report Form. This voluntary recall underscores the commitment to product reliability and patient safety within the medical device industry.