# China NMPA Product Recall - D-dimer detection kit (dry immunochromatography)

Source: https://www.globalkeysolutions.net/records/china_product_recall/alere-technologies-as-norway-co-ltd/2bb510cb-271c-41e5-a7bc-d25e74e683a9
Source feed: China

> China NMPA product recall for D-dimer detection kit (dry immunochromatography) by Alere Technologies AS (Norway) Co., Ltd. published January 02, 2020. Recall level: Level 1 Recall. On January 2, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Alere (Shanghai) Medical Device Sales Co., Ltd. is voluntarily recalling its D-dimer detection kit (dry immunochromatography).
- Company Name: Alere Technologies AS (Norway) Co., Ltd.
- Publication Date: 2020-01-02
- Product Name: D-dimer detection kit (dry immunochromatography)
- Recall Level: Level 1 Recall
- Recall Reason: Affected batches of the product may show lower results compared to other laboratory methods, below the clinical cutoff level (0.3 mg/L) for NycoCard D-Dimer, while other laboratory methods may detect D-Dimer results above the clinical cutoff level.
- Discovering Company: Alere (Shanghai) Medical Device Sales Co., Ltd.
- Manufacturing Company: Alere Technologies AS (Norway) Co., Ltd.
- Summary: On January 2, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class I recall initiated by Alere (Shanghai) Medical Device Sales Co., Ltd. The recall pertains to specific batches of their D-Dimer Detection Kit (Dry Immunochromatography), identified by Registration Certificate No.: 20142405787. This action was taken due to a critical performance issue where affected kits may yield D-Dimer results lower than the clinical cutoff level of 0.3 mg/L, even when other laboratory methods indicate levels above this threshold. This discrepancy presents a significant risk for potential misdiagnosis or delayed treatment, as patients requiring intervention might be incorrectly identified as having normal D-Dimer levels. Alere (Shanghai) Medical Device Sales Co., Ltd., acting on behalf of its parent company, Alere (Norway) Technologies AB, proactively reported this issue. The Class I designation signifies that the use of these defective products carries a reasonable probability of serious adverse health consequences or death. The recall mandates the company to retrieve all affected product models, specifications, and batches, with detailed information available in a comprehensive Medical Device Recall Event Report Form. This recall highlights the NMPA's stringent oversight and the manufacturer's responsibility in ensuring the safety and accuracy of medical diagnostic devices.

Company: https://www.globalkeysolutions.net/companies/alere-technologies-as-norway-co-ltd/08d8fe17-762c-4a13-b302-155e67f83549