China NMPA Product Recall - Cryostat

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its Cryostat cryostat machines on May 6, 2019. This action, overseen by the National Medical Products Administration (NMPA) and reported to the Shanghai Food and Drug Administration, resulted from critical findings during post-market monitoring. It was discovered that users were employing flammable cryostat sprays within the freezer compartments of the company's cryostat products. This practice introduced a substantial safety risk, as all flammable cryostat sprays are inherently combustible and could lead to serious injury if used improperly in this context. The primary regulatory issue identified was the inadequacy of the existing product labels on the cryostat machines, which conspicuously lacked essential warnings regarding the prohibition or hazards associated with using flammable cryostat sprays. Consequently, Leica Microsystems is required to implement corrective actions to update the product labels, ensuring comprehensive safety information is clearly communicated to users. Specific details concerning the impacted product models, specifications, and manufacturing batches are provided within the accompanying 'Medical Device Recall Event Report Form'.