# China NMPA Product Recall - Thyroxine Binding Ability Assay Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-laboratories/3aa8fb68-afed-4920-807a-07c2eb457448/
Source feed: China

> China NMPA product recall for Thyroxine Binding Ability Assay Kit by Abbott Laboratories published August 08, 2017. Recall level: Level 3 Recall. Abbott Laboratories, specifically Abbott Trading (Shanghai) Co., Ltd., initiated a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Laboratories is voluntarily recalling its thyroxine binding affinity assay kit.
- Company Name: Abbott Laboratories
- Publication Date: 2017-08-08
- Product Name: Thyroxine Binding Ability Assay Kit
- Recall Level: Level 3 Recall
- Recall Reason: Calibration failure/curve validity check failure may occur.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Laboratories
- Summary: Abbott Laboratories, specifically Abbott Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its Thyroxine Binding Ability Assay Kits. This action was announced by the National Medical Products Administration (NMPA) on August 8, 2017. The recall stemmed from identified issues, including potential calibration failures and curve validity check failures within the assay kits. The affected product, referenced by Registration Certificate No.: 20162404544, presented a quality concern that could impact its performance. A Class III recall signifies that the use of, or exposure to, the product is unlikely to cause adverse health consequences. Abbott Laboratories proactively undertook this recall to address the detected deficiencies and uphold product reliability and patient safety. Detailed information concerning specific models, specifications, and batch numbers of the impacted kits was provided in an accompanying "Medical Device Recall Event Report Form," as part of the NMPA's public notice. This voluntary recall demonstrates Abbott's commitment to regulatory compliance and maintaining the quality of its medical devices distributed in the market.

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