China NMPA Product Recall - CO2 incubator

Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. initiated a Level III voluntary recall for 57 units of its Carbon Dioxide Incubators (Model BB150) in China. This action, reported to the National Medical Products Administration (NMPA) on January 17, 2020, was prompted by a printing error on the product serial number label. The registration certificate number, "苏械注准20152220043," was incorrectly printed as "苏械注准20152." While the company confirmed that this typographical error did not compromise the product's safety, effectiveness, or customer use, it violated regulatory labeling requirements for medical devices. In response, the company outlined specific corrective actions. Unshipped incubators were to be isolated, reworked to correct the label, and then re-released for sale. For products already dispatched to the main distributor, they were identified and isolated upon receipt, with the distributor notified to prevent further circulation until the labels were rectified. However, for units confirmed as sold for general laboratory equipment use, no further traceability or correction was deemed necessary. This recall ensures compliance with NMPA's regulatory standards concerning medical device labeling.