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

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/4afe5cb2-b96e-4f9a-baad-546101254049/
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 Recall. Instrumentation Laboratory Co., via its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., ini

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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
- 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: Instrumentation Laboratory Co., via its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a voluntary Class II recall of its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method). This action, reported on August 10, 2017, and published by the National Medical Products Administration (NMPA) on August 15, 2017, addresses significant performance issues observed in specific batch numbers, notably N0177760 and N1166235. The primary concern arose from customer reports indicating that affected kits exceeded quality control limits and produced excessively long sample results, compromising the accuracy of in vitro quantitative detection for prothrombin time and fibrinogen concentration. Under the NMPA's regulatory framework, the company is required to cease all sales of the affected batches within China immediately. Furthermore, all existing inventory of these problematic batches in the Chinese market must be destroyed to prevent further use and ensure diagnostic reliability. While globally initiated, these corrective measures specifically target the Chinese distribution to mitigate potential risks associated with inaccurate diagnostic results.

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