China NMPA Product Recall - Cryostat

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its Cryostat cryostat machines, announced on May 6, 2019, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. This action followed post-market monitoring, which identified a significant safety concern: users were found to be applying flammable cryostat spray within the product's freezer compartment. The primary issue stemmed from an inadequacy in the product labeling. While all flammable cryostat sprays inherently carry a risk of flammability and potential for serious injury, the current labels on Leica Microsystems' cryostats did not provide explicit warnings regarding the use of such flammable sprays. This omission created an unforeseen hazard for users. As a result, Leica Microsystems (Shanghai) Trading Co., Ltd. proactively recalled its Cryostat cryostats, specifically those under Registration Certificate No.: 20150367. The "Medical Device Recall Event Report Form" contains detailed information regarding affected product models, specifications, and batches. This recall underscores the importance of comprehensive product labeling to ensure user safety and compliance with medical device regulations.