China NMPA Product Recall - Eluent for Glycated Hemoglobin Analysis (English name: ELUENT 80A) and Eluent for Glycated Hemoglobin Analysis (English name: ELUENT 80B)

Aikelai Medical Technology (Pinghu) Co., Ltd. initiated a voluntary Level 3 recall on October 17, 2018, for its Glycated Hemoglobin Analysis Eluent (ELUENT 80A and ELUENT 80B), as reported to the National Medical Products Administration (NMPA). The recall stemmed from non-standard expiration date labeling on these in-vitro diagnostic reagents. The company noted a lack of clear regulatory guidelines for expiration date calculation methods for such reagents, leading them to use internal labeling procedures. Under the guidance of the Pinghu City Food and Drug Administration, Aikelai Medical Technology committed to standardizing its labeling practices by referencing Article 23 of the "Regulations on the Management of Drug Instructions and Labels." This proactive measure aims to ensure product quality and regulatory compliance. The recall impacted six batches of ELUENT 80A (335 boxes) and four batches of ELUENT 80B (286 boxes). As required actions, Aikelai Medical Technology will have Aikelai International Trading (Shanghai) Co., Ltd. (AMS) return all inventory for relabeling. For products already distributed to lower-level agents and end-users, correct labels will be provided for self-correction, along with notifications to ensure proper use according to the updated validity periods.