# China NMPA Product Recall - Thromboelastography test kit (platelet-AA and ADP reagents) (coagulation method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-maiketian-biomedical-technology-co-ltd/c8464d73-4b84-44a6-b7a6-440341b2e922/
Source feed: China

> China NMPA product recall for Thromboelastography test kit (platelet-AA and ADP reagents) (coagulation method) by Shenzhen Maiketian Biomedical Technology Co., Ltd. published March 11, 2021. Recall level: Level 3 Recall. Shenzhen Maiketian Biomedical Technology Co., Ltd. initiated a voluntary Class III recall on March 1

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Maiketian Biomedical Technology Co., Ltd. is voluntarily recalling its thromboelastography test kit (platelet-AA and ADP reagents) (coagulation method).
- Company Name: Shenzhen Maiketian Biomedical Technology Co., Ltd.
- Publication Date: 2021-03-11
- Product Name: Thromboelastography test kit (platelet-AA and ADP reagents) (coagulation method)
- Recall Level: Level 3 Recall
- Recall Reason: Two batches of thromboelastography test kits (platelet-AA and ADP reagents) (coagulation method) kits had printing errors on the label of component activator AA.
- Discovering Company: Shenzhen Maiketian Biomedical Technology Co., Ltd.
- Manufacturing Company: Shenzhen Maiketian Biomedical Technology Co., Ltd.
- Summary: Shenzhen Maiketian Biomedical Technology Co., Ltd. initiated a voluntary Class III recall on March 11, 2021, for specific batches of its Thromboelastography Test Kits (Platelet-AA and ADP Reagents) (Coagulation Method). This action was taken due to a significant printing error identified on the label of the component activator AA within two affected product batches. The recall was announced by the National Medical Products Administration (NMPA), with information sourced from the Guangdong Provincial Drug Administration Website, underscoring the regulatory oversight in place. A Class III recall indicates that while the defect is unlikely to cause serious adverse health consequences, it still violates regulatory standards and warrants removal from the market. The company is responsible for ensuring the accuracy and safety of its medical devices, and this labeling discrepancy necessitated corrective action to maintain product integrity and compliance. Further specifics regarding the recalled product specifications and batch numbers are detailed in the associated "Medical Device Recall Event Report Form." This proactive measure by Shenzhen Maiketian Biomedical Technology Co., Ltd. aligns with NMPA's framework for managing medical device safety and quality issues.

Company: https://www.globalkeysolutions.net/companies/shenzhen-maiketian-biomedical-technology-co-ltd/185cb28b-5cce-4651-a113-914dfbc06b9d/