# China NMPA Product Recall - C-peptide assay kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/soling-diagnostics-medical-equipment-shanghai-co-ltd/a78993c3-29e2-4871-a438-e0192e8ab6a6/
Source feed: China

> China NMPA product recall for C-peptide assay kit by Soling Diagnostics Medical Equipment (Shanghai) Co., Ltd. published May 08, 2017. Recall level: Level 3 Recall. Soling Diagnostics Medical Devices (Shanghai) Co., Ltd. initiated a voluntary recall of its C-Peptid

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Soling Diagnostics Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its C-peptide assay kits.
- Company Name: Soling Diagnostics Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: C-peptide assay kit
- Recall Level: Level 3 Recall
- Recall Reason: The C-peptide assay kit exhibits a cross-reactivity with human proinsulin greater than the cross-reactivity rate stated in the current version of the instructions. In rare cases, this cross-reactivity may result in a significantly elevated C-peptide value in affected samples tested using this kit.
- Discovering Company: Soling Diagnostics Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Soling Diagnostics Medical Equipment (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/soling-diagnostics-medical-equipment-shanghai-co-ltd/66b2d3af-4c31-4b8b-a03f-37b937c60a85/