# China NMPA Product Recall - Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/d480fb29-ea7b-4e3c-a61a-983dd1f21db8/
Source feed: China

> China NMPA product recall for Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method) by Instrumentation Laboratory Co. published October 30, 2017. Recall level: Level 2. Instrumentation Laboratory Co., through its agent Wofen Medical Device Trading (Beijing) Co., Ltd., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Instrumentation Laboratory Co. is voluntarily recalling its prothrombin time and fibrinogen assay kits (coagulation method).
- Company Name: Instrumentation Laboratory Co.
- Publication Date: 2017-10-30
- Product Name: Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method)
- Recall Level: Level 2
- Recall Reason: Regarding customer reports on performance issues with the Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method), which reported some kits exceeding quality control limits and sample results being too long, investigation revealed two additional affected batches, N0278358 and N0479057.
- Discovering Company: Wofen Medical Equipment Trading (Beijing) Co., Ltd.
- Manufacturing Company: Instrumentation Laboratory Co.
- Summary: Instrumentation Laboratory Co., through its agent Wofen Medical Device Trading (Beijing) Co., Ltd., initiated a voluntary Level II recall of its Prothrombin Time and Fibrinogen Assay Kits (Coagulation Method). This action, reported to the National Medical Products Administration (NMPA) on October 26, 2017, and published on October 30, 2017, was prompted by customer reports of significant performance issues. Specifically, some kits, designed for in vitro quantitative detection of prothrombin time and fibrinogen concentration, exceeded quality control limits and produced excessively long results. Subsequent investigations identified two additional affected batches: N0278358 and N0479057. Under NMPA regulations, Wofen Medical Device Trading (Beijing) Co., Ltd. took several corrective actions. They immediately ceased sales of the affected batches within China, issued recall notices to customers requesting product returns, and offered replacement batches. Furthermore, all remaining inventory of the two affected batches in China, along with the products recalled from customers, were destroyed to prevent further use. While managed by the agent in China, this recall was declared as a global effort.

Company: https://www.globalkeysolutions.net/companies/instrumentation-laboratory-co/fe42e432-39e1-4428-9245-848558cb2c0a/