China NMPA Product Recall - C-peptide assay kit

Soling Diagnostics Medical Devices (Shanghai) Co., Ltd. initiated a voluntary recall of its C-Peptide Assay Kit, as reported on May 8, 2017, under the oversight of the National Medical Products Administration (NMPA). The recall was prompted by customer complaints and confirmed by the manufacturer's internal testing, revealing a critical issue with the kit's performance.The primary concern is that the cross-reactivity of the C-peptide assay kit with human proinsulin is greater than the rate specified in the product's instructions. This discrepancy is significant because, in some rare instances, it can lead to a considerable increase in the C-peptide values detected in affected patient samples. Such inaccurate results could potentially misguide clinical decisions.In response to this confirmed defect, Soling Diagnostics Medical Devices (Shanghai) Co., Ltd. has categorized this as a Level III recall, indicating a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. The company has taken steps to remove the relevant products from the market. Detailed information regarding the specific models, specifications, and batch numbers of the recalled C-Peptide Assay Kits is provided in the accompanying "Medical Device Recall Event Report Form" attachment for stakeholders and users.