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

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/1c1e8501-ee94-485a-a714-ac1f8b76d003/
Source feed: China

> China NMPA product recall for Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method) by Instrumentation Laboratory Co. published August 15, 2017. Recall level: Level 2. The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated 

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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: 2017-08-15
- Product Name: Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method)
- Recall Level: Level 2
- Recall Reason: IL recently received a report from a customer regarding performance issues with its prothrombin time and fibrinogen assay kits (coagulation method). The feedback indicated that some kits with batch numbers N1166235 and N0177760 had exceeded quality control limits and the sample results were too long.
- Discovering Company: Wofen Medical Equipment Trading (Beijing) Co., Ltd.
- Manufacturing Company: Instrumentation Laboratory Co.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Instrumentation Laboratory Co. on August 15, 2017. The recall, reported by its agent Wofen Medical Devices Trading (Beijing) Co., Ltd. on August 10, 2017, addresses performance issues with specific batches of their Prothrombin Time and Fibrinogen Assay Kits (Clotting Method). The affected product, identified by Registration No. 20152402017 and specifically impacting batch numbers N0177760 and N1166235, was found to have kits exceeding quality control limits and producing excessively long sample results. This issue could potentially affect the accuracy of in vitro quantitative detection of prothrombin time and fibrinogen concentration. Operating under the NMPA’s regulatory framework, Instrumentation Laboratory Co. and its agent are required to take immediate corrective actions. These include halting the sale of all affected product batches in China and destroying all remaining inventory of batch numbers N0177760 and N1166235 within China. While the recall applies globally, the specific sales quantity for affected products in China was reported as zero for batch N0177760. A Class II recall indicates that the product's use may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

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