China NMPA Product Recall - Aiko blood glucose testing system, blood glucose meter

Aikon Biotechnology (Hangzhou) Co., Ltd. initiated a voluntary Class III recall of its Aikon Blood Glucose Testing Systems and Meters, a decision published by the National Medical Products Administration (NMPA) on November 30, 2018. This action followed a quality supervision assessment which identified that the outer packaging of the medical devices lacked clear transportation and storage condition information. Specifically, while the product instructions detailed a storage temperature range of -20 to 50℃, this critical information was not explicitly present on the product packaging.

In response, the company proactively recalled all affected batches. Required actions include notifying impacted customers, isolating and updating packaging for unsold products, and revising product labels to clearly state the storage conditions. Aikon Biotechnology also committed to reinforcing the importance of referring to product instructions. The company emphasized that the original packaging oversight did not negatively impact product performance or user safety, therefore, affected products do not need to be removed from customer possession, and discontinuation of the product is not mandated. The company's official recall report was submitted on November 23, 2018.