China NMPA Product Recall - Glycated hemoglobin washing solution (English name: Hemolysis Washing Solution 80H), Glycated hemoglobin washing solution (English name: Hemolysis Washing Solution Lite H)

Aikelai Medical Technology (Pinghu) Co., Ltd. initiated a voluntary Level III recall, announced on October 23, 2018, for its Glycated Hemoglobin Washing Solution (Hemolysis Washing Solution 80H) and Protamine Washing Solution (Hemolysis Washing Solution Lite H). The recall stems from non-standard expiration date labeling practices. The company noted that regulations for in vitro diagnostic reagents lacked explicit guidance on expiration date calculation, leading them to use internal standards which were later found to be inconsistent with regulatory interpretation.

Under guidance from the Pinghu City Food and Drug Administration, Aikelai Medical Technology is standardizing its labeling in accordance with Article 23 of the "Regulations on the Management of Drug Instructions and Labels" (State Food and Drug Administration Order No. 24).

The recall affects 49 batches (7,595 boxes) of Hemolysis Washing Solution 80H and 5 batches (250 boxes) of Hemolysis Washing Solution Lite H across China. For 12 batches (1,860 boxes) of Solution 80H with less than three months' shelf life, the company will recall and replace products. For the remaining 37 batches (5,735 boxes) of Solution 80H and all 5 batches (250 boxes) of Solution Lite H, which were distributed through AMS International Trading (Shanghai) Co., Ltd., AMS will return its inventory for relabeling. Lower-level agents and end-users will receive correct labels for self-correction and instructions to adhere to the revised validity periods.