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

Source: https://www.globalkeysolutions.net/records/china_product_recall/aikelai-medical-technology-pinghu-co-ltd/92e97e1b-fb1a-4208-8267-e3718b3c5308/
Source feed: China

> China NMPA product recall for Glycated hemoglobin washing solution (English name: Hemolysis Washing Solution 80H), Glycated hemoglobin washing solution (English name: Washing Solution Lite H) by Aikelai Medical Technology (Pinghu) Co., Ltd. published October 23, 2018. Recall level: Level 3 Recall. Aikelai Medical Technology (Pinghu) Co., Ltd. initiated a voluntary Class III recall of its glycated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Aikelai Medical Technology (Pinghu) Co., Ltd. voluntarily recalls glycated hemoglobin lysing agent
- Company Name: Aikelai Medical Technology (Pinghu) Co., Ltd.
- Publication Date: 2018-10-23
- Product Name: Glycated hemoglobin washing solution (English name: Hemolysis Washing Solution 80H), Glycated hemoglobin washing solution (English name: Washing Solution Lite H)
- Recall Level: Level 3 Recall
- Recall Reason: Because its glycated hemoglobin lysing agent has an irregular expiration date labeling.
- Discovering Company: Aikelai Medical Technology (Pinghu) Co., Ltd.
- Manufacturing Company: Aikelai Medical Technology (Pinghu) Co., Ltd.
- Summary: Aikelai Medical Technology (Pinghu) Co., Ltd. initiated a voluntary Class III recall of its glycated hemoglobin washing solutions, specifically "Hemolysis Washing Solution 80H" and "Washing Solution Lite H," as reported to the National Medical Products Administration (NMPA) on October 17, 2018. The primary issue identified was non-standard expiration date labeling on these in vitro diagnostic reagents. Although the company had followed its internal guidelines for expiry date determination, current NMPA regulations lacked clear, specific calculation methods for such reagents, leading to a discrepancy. Under guidance from the Pinghu Municipal Food and Drug Administration, Aikelai Medical Technology proactively invoked Article 23 of the "Regulations on the Management of Drug Instructions and Labels" to standardize its labeling practices. The required actions for the recall involved different approaches based on product distribution and remaining shelf life. For 12 batches (1,860 boxes) of Hemolysis Washing Solution 80H with less than three months of shelf life, the company committed to recalling and replacing them directly with customers. For the remaining 37 batches (5,735 boxes) of Solution 80H and 5 batches (250 boxes) of Solution Lite H, which were distributed through AMS International Trading (Shanghai) Co., Ltd., AMS was instructed to return its inventory for relabeling. Furthermore, for products already sold to downstream agents and end-users, Aikelai Medical Technology arranged for the distribution of correct labels, empowering users to self-correct and adhere to the updated validity periods. These measures aim to ensure regulatory compliance and product quality.

Company: https://www.globalkeysolutions.net/companies/aikelai-medical-technology-pinghu-co-ltd/168b0851-58f3-425a-8ce4-0bc0aa438724/