China NMPA Product Recall - Cryostat

Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall for its Cryostat cryostat machines, as reported by the National Medical Products Administration (NMPA) on May 6, 2019. This action followed post-market surveillance that identified a critical safety oversight: the cryostat machines' labels lacked explicit warnings against using flammable cryostat sprays within their freezer compartments. The company determined that such sprays, when used in the device, pose a serious flammability risk, potentially leading to significant user injury. While flammable sprays typically carry their own warnings, the absence of corresponding warnings on the cryostat machines necessitated immediate corrective measures. The recall, impacting specific models and batches, is detailed in a "Medical Device Recall Event Report Form." This action highlights the company's responsibility under the NMPA regulatory framework to address product safety deficiencies. The required action involves updating product labeling to clearly advise against the use of flammable materials in the device's freezer, thereby mitigating the identified hazard and reinforcing user safety. This proactive recall demonstrates Leica Microsystems' commitment to preventing potential harm and maintaining robust product safety standards.