# China NMPA Product Recall - ARCHITECT Anti-Tg Reagent Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-laboratories/5005bc06-8d4a-47ab-8532-8520545e3e8d/
Source feed: China

> China NMPA product recall for ARCHITECT Anti-Tg Reagent Kit (Chemiluminescent Microparticle Immunoassay) by Abbott Laboratories published January 31, 2023. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) of China published an announcement on January 31

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Laboratories is voluntarily recalling its ARCHITECT Anti-Tg Reagent Kit (chemiluminescent microparticle immunoassay).
- Company Name: Abbott Laboratories
- Publication Date: 2023-01-31
- Product Name: ARCHITECT Anti-Tg Reagent Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with the label lacking the required product license number.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Laboratories
- Summary: The National Medical Products Administration (NMPA) of China published an announcement on January 31, 2023, regarding a voluntary Class III recall initiated by Abbott Laboratories, Inc. This recall pertains to specific models and batches of their ARCHITECT Anti-Tg Reagent Kit (Chemiluminescent Microparticle Immunoassay). Abbott Trading (Shanghai) Co., Ltd., the local entity, reported the issue, which centered on a critical labeling non-conformance. The main violation identified was the absence of the mandatory product license number on the labels of the affected diagnostic reagent kits. Under the NMPA's stringent regulatory framework for medical devices, accurate and complete labeling, including the product license number, is a fundamental requirement to ensure product traceability and regulatory compliance. The omission of this essential information triggered the recall. Abbott Laboratories, as the manufacturer, is undertaking this voluntary Class III recall as the required action to rectify the labeling deficiency. Further detailed information, including specific registration numbers, product specifications, and batch numbers impacted by this recall, is provided in the accompanying 'Medical Device Recall Event Report Form' made available by Abbott Trading (Shanghai) Co., Ltd. This action underscores the NMPA's commitment to upholding medical device safety and regulatory standards within its jurisdiction.

Company: https://www.globalkeysolutions.net/companies/abbott-laboratories/1b90ea06-9339-4fec-845b-7b265e8fee86/