China NMPA Product Recall - Cryostat

On May 6, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall for its Cryostat cryostat machines (Registration Certificate No.: 20161064). This action stemmed from post-market monitoring observations revealing that some users were employing flammable cryostat sprays within the product's freezer compartment. The critical issue identified was the absence of explicit warnings on the cryostat machine labels concerning the potential flammability and serious injury risks associated with these sprays. Overseen by the National Medical Products Administration (NMPA), this recall underscores a significant safety oversight. Leica Microsystems (Shanghai) Trading Co., Ltd. is required to implement corrective measures, primarily enhancing product labeling to clearly communicate the hazards of flammable cryostat sprays. This ensures user safety and adherence to regulatory requirements. Specific details regarding affected product models, specifications, and batches are provided in the comprehensive Medical Device Recall Event Report Form.