China NMPA Product Recall - Cryostat

On May 6, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a Class II voluntary recall of its Cryostat cryostat machines (Registration Certificate No.: 20180127). This action was taken under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by post-market monitoring, which revealed a significant safety issue: users were found to be operating the cryostat machines with flammable cryostat sprays in the freezer compartment. The primary violation identified was the critical absence of appropriate safety warnings on the cryostat machine labels, which failed to caution against or prohibit the use of such flammable sprays. While the sprays themselves inherently pose a flammability risk, the deficiency in the machine's labeling created a potential for serious user injury. As a required action, Leica Microsystems (Shanghai) Trading Co., Ltd. is implementing improvement measures to ensure that clear warnings regarding the use of flammable cryostat sprays are prominently displayed on the cryostat machine labels, thereby mitigating the identified safety hazard and ensuring compliance with safety standards.