# China NMPA Product Recall - Thyroxine binding capacity calibrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-laboratories/b5e1d760-0cca-4d12-84d8-381d41f02a99/
Source feed: China

> China NMPA product recall for Thyroxine binding capacity calibrator by Abbott Laboratories published April 13, 2016. Recall level: . The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Abbott

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Laboratories recalls thyroxine binding capacity calibrators.
- Company Name: Abbott Laboratories
- Publication Date: 2016-04-13
- Product Name: Thyroxine binding capacity calibrator
- Recall Reason: Abbott has discovered a stability issue with the thyroxine binding capacity calibrators in the affected batches, which could potentially cause quality control samples to exceed acceptable limits.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Laboratories
- Summary: The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Abbott Laboratories regarding its Thyroxine Binding Ability Calibrators. Abbott Trading (Shanghai) Co., Ltd. reported stability issues with specific product batches (614719, 650124, 697989), which possess registration certificate number CFDA (Imported) 2013 No. 2404850. These calibrators are intended for use with the ARCHITECTI system to quantify total thyroxine binding power in human serum or plasma. The primary issue identified was a stability problem that could lead to quality control samples exceeding their specified ranges. Abbott Laboratories reported this voluntary recall on March 7, 2016, with the NMPA publishing the notice on April 13, 2016. A key finding was that the affected batches were not sold or imported into China. Therefore, Abbott Diagnostics was not required to take corrective actions within the Chinese market. However, the NMPA directed all provincial food and drug administrations to reinforce their supervision and management over similar medical products.

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