# China NMPA Product Recall - Insulin Assay Kit (Chemiluminescence Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/7d9730bd-f225-4ef1-a4a9-9eba485ffaa3/
Source feed: China

> China NMPA product recall for Insulin Assay Kit (Chemiluminescence Method) by Siemens Healthcare Diagnostics Inc. published May 23, 2012. Recall level: . Siemens Healthcare Diagnostics Inc. initiated a voluntary global recall of specific batches of its I

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthcare Diagnostics Inc. is recalling its insulin assay kits (chemiluminescence assay).
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2012-05-23
- Product Name: Insulin Assay Kit (Chemiluminescence Method)
- Recall Reason: Using the aforementioned batch of kits, a negative bias occurs at insulin values below 10 µIU/mL, and the imprecision increases compared to representative study data in the instructions. This negative bias and increased imprecision at the low end may delay the detection of early progression of insulin resistance, which typically progresses over a long period (up to decades). Therefore, using the affected kits is unlikely to cause serious health effects; no adverse events have been reported in China to date.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Healthcare Diagnostics Inc. initiated a voluntary global recall of specific batches of its Insulin Assay Kits (Chemiluminescence Method), as reported by China's National Medical Products Administration (NMPA) on May 23, 2012. The recall was prompted by significant quality issues identified in the affected products, specifically a negative bias and increased imprecision when measuring insulin values below 10 µIU/mL. This inaccuracy could potentially delay the detection of early progression of insulin resistance. While no adverse events had been reported in China to date, the manufacturer, through its responsible unit Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., took proactive steps. The affected batches included LKINI: 0335, and L2KIN2/L2KIN6: 312, 313, 314, 315, 316. Under the regulatory oversight of the NMPA and local food and drug administrations, Siemens Healthcare Diagnostics Inc. instructed customers to immediately cease selling and using the recalled kits. The company also initiated a replacement program for all affected products. The NMPA mandated provincial regulatory bodies to enhance supervision of similar diagnostic products to ensure public health and safety.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/