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

Source: https://www.globalkeysolutions.net/records/china_product_recall/aikon-biotechnology-hangzhou-co-ltd/8c75ff0a-c78e-4962-9fca-65e9db4e86ce/
Source feed: China

> China NMPA product recall for Aiko blood glucose testing system, blood glucose meter by Aikon Biotechnology (Hangzhou) Co., Ltd. published November 30, 2018. Recall level: Level 3 Recall. Aikon Biotechnology (Hangzhou) Co., Ltd. initiated a voluntary Class III recall of its Aikon Blood G

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Acon Biotechnology (Hangzhou) Co., Ltd. has initiated a voluntary recall of its Acon blood glucose testing system and blood glucose meter.
- Company Name: Aikon Biotechnology (Hangzhou) Co., Ltd.
- Publication Date: 2018-11-30
- Product Name: Aiko blood glucose testing system, blood glucose meter
- Recall Level: Level 3 Recall
- Recall Reason: During a national medical device quality supervision and spot check, it was found that the outer packaging of the product lacked transportation and storage conditions. In order to strengthen the use of product instructions and labels, the company decided to clearly indicate the storage temperature range on the product packaging and to proactively recall the affected batches of products.
- Discovering Company: Aikon Biotechnology (Hangzhou) Co., Ltd.
- Manufacturing Company: Aikon Biotechnology (Hangzhou) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/aikon-biotechnology-hangzhou-co-ltd/f05eec38-79b8-446c-b2dc-bed7477f2281/