# China NMPA Product Recall - Mycobacterium tuberculosis specific cellular immunoreaction detection kit (immunospot assay) T-SPOT.TB, sample density separation solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/oxford-immunotec-ltd/bdb1238b-f233-4656-820b-e4f1f5d624db/
Source feed: China

> China NMPA product recall for Mycobacterium tuberculosis specific cellular immunoreaction detection kit (immunospot assay) T-SPOT.TB, sample density separation solution by Oxford Immunotec Ltd. published November 14, 2022. Recall level: Level 2 Recall. Oxford Immunotec Ltd., specifically through its subsidiary Oufode (Shanghai) Medical Devices Co., Lt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Oxford Immunotec Ltd. is actively recalling its Mycobacterium tuberculosis-specific cellular immunoreactivity detection kit (immunospot assay) T-SPOT.TB and sample density separation solution.
- Company Name: Oxford Immunotec Ltd.
- Publication Date: 2022-11-14
- Product Name: Mycobacterium tuberculosis specific cellular immunoreaction detection kit (immunospot assay) T-SPOT.TB, sample density separation solution
- Recall Level: Level 2 Recall
- Recall Reason: This involves specific models and batches of products stored above the verification temperature range of 2~8℃, exceeding the stress test support in the initial real-time stability study.
- Discovering Company: Ouford (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Oxford Immunotec Ltd.
- Summary: Oxford Immunotec Ltd., specifically through its subsidiary Oufode (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class II recall of its Mycobacterium tuberculosis-specific cellular immune response detection kit (T-SPOT.TB) and related sample density separation solution. This action, publicly reported by the National Medical Products Administration (NMPA) on November 14, 2022, addresses a significant product quality concern. The primary issue identified was that certain models and batches of the products were stored at temperatures above their validated range of 2-8℃. This storage deviation exceeded the parameters supported by stress tests conducted during the initial real-time stability studies, potentially impacting product efficacy and safety. The required action involves the recall of affected products, with detailed information on specific models, specifications, and batch numbers provided in a "Medical Device Recall Event Report Form." This recall highlights the critical importance of maintaining strict adherence to validated storage conditions to ensure the reliability and integrity of medical devices under the regulatory framework of the NMPA.

Company: https://www.globalkeysolutions.net/companies/oxford-immunotec-ltd/5c0721ec-20a0-44db-88d1-cb93bf67f938/