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Evaluating regulatory oversight through major in vitro diagnostic recalls: a retrospective study of FDA data (2015-2024).

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Title: Evaluating regulatory oversight through major in vitro diagnostic recalls: a retrospective study of FDA data (2015-2024).
Authors: Simran S; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India., Thakur A; Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India., Ahire AK; Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India., Srivastava S; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India., Asthana A; Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.
Source: Expert review of medical devices [Expert Rev Med Devices] 2026 Jun; Vol. 23 (6), pp. 723-731. Date of Electronic Publication: 2026 May 12.
Publication Type: Journal Article
Journal Info: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101230445 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1745-2422 (Electronic) Linking ISSN: 17434440 NLM ISO Abbreviation: Expert Rev Med Devices Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Simran+S%22">Simran S</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Thakur+A%22">Thakur A</searchLink>; Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Ahire+AK%22">Ahire AK</searchLink>; Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Srivastava+S%22">Srivastava S</searchLink>; Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Asthana+A%22">Asthana A</searchLink>; Department of Medical Devices, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.
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  Data: <searchLink fieldCode="JN" term="%22101230445%22">Expert review of medical devices</searchLink> [Expert Rev Med Devices] 2026 Jun; Vol. 23 (6), pp. 723-731. <i>Date of Electronic Publication: </i>2026 May 12.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Taylor+%26+Francis%22">Taylor & Francis </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101230445 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1745-2422 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217434440%22">17434440 </searchLink><i>NLM ISO Abbreviation: </i>Expert Rev Med Devices <i>Subsets: </i>MEDLINE
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        Value: 10.1080/17434440.2026.2669127
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      – Code: eng
        Text: English
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            NameFull: Simran S
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            NameFull: Thakur A
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            NameFull: Ahire AK
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              M: 06
              Text: 2026 Jun
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            – TitleFull: Expert review of medical devices
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