# China NMPA Product Recall - Free triiodothyronine assay kit, total triiodothyronine assay kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/e972ce08-54be-46b6-a825-aef2d7dd593f/
Source feed: China

> China NMPA product recall for Free triiodothyronine assay kit, total triiodothyronine assay kit by Abbott Trading (Shanghai) Co., Ltd. published October 29, 2018. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Free Triiodothyro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. has voluntarily recalled its Free Triiodothyronine Assay Kit and Total Triiodothyronine Assay Kit.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2018-10-29
- Product Name: Free triiodothyronine assay kit, total triiodothyronine assay kit
- Recall Level: Level 3 Recall
- Recall Reason: When products affected by the contamination are tested simultaneously with certain items, the sample results may be falsely reduced due to actual contamination carried over.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Free Triiodothyronine Assay Kit (Chemiluminescent Microparticle Immunoassay) and Total Triiodothyronine Assay Kit. This significant action was publicly announced on October 29, 2018, under the regulatory guidance of the National Medical Products Administration (NMPA) and referenced by the Shanghai Food and Drug Administration's medical device recall notice (2018-264). The critical issue prompting this recall is the potential for affected product batches to produce falsely low sample results. This inaccuracy occurs when the kits are tested simultaneously with certain other items within a machine, with the root cause identified as actual contamination. Such erroneous results could significantly impact diagnostic accuracy, potentially leading to incorrect patient management or delayed medical interventions. The recall requires Abbott Trading (Shanghai) Co., Ltd. to remove the affected products from the market to ensure the integrity of diagnostic testing. The company provided detailed information, including specific models, specifications, and batch numbers of the impacted products, in the "Medical Device Recall Event Report Form" for stakeholders to identify and manage affected inventory. This proactive measure by the company, overseen by the NMPA, underscores the importance of maintaining high standards in medical device quality and safety to protect public health and ensure reliable diagnostic outcomes.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/