# China NMPA Product Recall - PT and FIB assay kit (coagulation method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/instrumentation-laboratory-co/edcd6b8d-124f-4dda-a0ab-4f7e07e9cdb7/
Source feed: China

> China NMPA product recall for PT and FIB assay kit (coagulation method) by Instrumentation Laboratory Co. published December 12, 2014. Recall level: Level II. Wofen Medical Equipment International Trading (Shanghai) Co., Ltd., in collaboration with manufactur

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Werfen Medical Equipment International Trading (Shanghai) Co., Ltd. is voluntarily recalling its PT and FIB assay kits (coagulation method).
- Company Name: Instrumentation Laboratory Co.
- Publication Date: 2014-12-12
- Product Name: PT and FIB assay kit (coagulation method)
- Recall Level: Level II
- Recall Reason: Some reagent vials from these older batches turned yellow/brown instead of the typical off-white color after reconstitution. This yellow/brown color can lead to prolonged PT solidification time; some quality control reports indicate it exceeds the stability range, and its use should be discontinued.
- Discovering Company: Wofen Medical Equipment International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Instrumentation Laboratory Co.
- Summary: Wofen Medical Equipment International Trading (Shanghai) Co., Ltd., in collaboration with manufacturer Instrumentation Laboratory Co., initiated a voluntary Class II recall of specific batches of their PT and FIB Assay Kits (Coagulation Method). This action, reported to the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration on December 12, 2014, addresses a significant quality issue concerning product integrity. The primary concern is that certain reagent vials, from batches N1222324 through N0148094 with expiry dates ranging from December 2014 to December 2015, exhibit an abnormal yellow/brown discoloration upon reconstitution, deviating from the expected off-white appearance. This color change signifies that the reagent exceeds its stability range, potentially leading to prolonged Prothrombin Time (PT) solidification. Such an issue renders the diagnostic results unreliable for assessing extrinsic coagulation pathways and monitoring anticoagulant therapy. As immediate corrective actions, users are instructed to discontinue using any reagent vials that show yellow/brown discoloration after reconstitution, discarding them and utilizing unaffected reagents. Wofen distributed a "Safety Notice" and "Feedback Tracking Form" to all affected distributors and users, with its Quality Assurance Department tracking user feedback to ensure a 75% response rate by April 30, 2015, thereby ensuring adherence to the recall directives.

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