China NMPA Product Recall - Thyroglobulin Assay Kit (Chemiluminescence Method)

Soling Diagnostics Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Thyroglobulin Assay Kit (Chemiluminescence Method). This action, publicly reported by the Shanghai Food and Drug Administration on September 30, 2019, under the Medical Device Recall 2019-239, was prompted by significant labeling and documentation deficiencies. The main violations included the complete absence of a product standard number printed on the Chinese label of the kit. Furthermore, this essential product standard number was also not incorporated into the kit's instructions for use, impacting clarity and traceability. The recall specifically pertains to products covered by Registration Certificate No.: 20152400591. The company's voluntary recall reflects its commitment to rectify these identified non-compliances with medical device product information requirements. While specific inspection dates are not provided, the prompt corrective action underscores the importance of accurate and complete product documentation within the regulatory framework governing medical devices. The Class III classification suggests a low probability of adverse health consequences, yet correction is imperative to ensure proper product identification and user information.