China NMPA Product Recall - Factor XII Detection Kit (Coagulation Method)

Instrumentation Laboratory Co. initiated a voluntary Class III recall for specific batches of its Factor XII Detection Kit (Coagulation Method). The recall, reported to the National Medical Products Administration (NMPA) on July 31, 2017, stemmed from an internal identification that the product did not meet its declared onboard stability on ACL Top family instruments. The kit, specified to be stable for 24 hours at 15°C, was found to have an actual stability of only 2 hours. This discrepancy affects the reliable detection of coagulation factor II activity in patient samples.

The recall impacts 117 units in China (product code 0020011200, models N1065905, N0764104, N0958653) and is global in scope. Required actions include the immediate discontinuation of sales for affected batches. Furthermore, customers are being notified via an urgent letter to inform them of the revised 2-hour onboard stability. The company mandates the retention of these customer notifications and associated feedback as proof of compliance, ensuring users are aware of the updated stability for accurate diagnostic testing.