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

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/e131c42e-e860-4a5f-af20-b1147fbfae65/
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 Recall. Instrumentation Laboratory Co., via its agent Wofen Medical Device Trading (Beijing) Co., Ltd., cond

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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
- 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., via its agent Wofen Medical Device Trading (Beijing) Co., Ltd., conducted a voluntary Level II recall of its Prothrombin Time and Fibrinogen Assay Kits (Clotting Method) in October 2017. This action was initiated due to customer reports detailing performance issues, specifically that certain kits exceeded quality control limits and yielded excessively long results. Two batches, N0278358 and N0479057, were identified as affected. This recall was managed under the regulatory framework of the National Medical Products Administration (NMPA) of China, for a product with registration number 国械注进20152402017. The recall had a global scope, with 150 affected units sold in China. Required actions included Wofen Medical Devices Trading (Beijing) Co., Ltd. ceasing sales of the identified batches in China, dispatching recall notices to customers requesting the return of affected products, providing replacement batches, and destroying all remaining inventory and successfully recalled products to ensure public safety.

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