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

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/e5f5ca9c-fec7-4fbf-9d81-ae70777e78b2/
Source feed: China

> China NMPA product recall for Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method) by Instrumentation Laboratory Co. published August 21, 2017. Recall level: Level 2 Recall. Instrumentation Laboratory Co., through its agent Wofen Medical Devices 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: 2017-08-21
- 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., through its agent Wofen Medical Devices Trading (Beijing) Co., Ltd., initiated a voluntary Level II recall for specific batches of its Prothrombin Time and Fibrinogen Assay Kit (Coagulation Method). This action, reported on August 10, 2017, and published by the National Medical Products Administration (NMPA) on August 21, 2017, followed recent customer complaints regarding the product's performance. The primary issue, identified in batch numbers N1166235 and N0177760, indicated that some kits exceeded quality control limits, resulting in excessively long sample results. These performance deficiencies could compromise the accurate quantitative detection of prothrombin time and fibrinogen concentration in plasma. Operating under the NMPA's regulatory framework, a Level II recall signifies a situation where the use of a non-conforming product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a corrective action, Instrumentation Laboratory Co. mandated a global recall, with specific instructions for China to immediately cease sales and destroy all existing inventory of the two affected batches within the country. This measure aims to prevent further distribution and use of the non-conforming diagnostic kits.

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