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Fujirebio Diagnostics, Inc.

US Last updated 23 Oct 2026

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Devices
69
Registries
GUDIDEUDAMEDFDA 510(k)FDA
FDA recalls
87 ongoing

Catalogue69

Page 1 of 2

Showing 1-50 of 69

FDA recalls8

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Fujirebio Diagnostics, Inc. has eight recall records initiated between July 29, 2010, and December 11, 2025. The records include instances classified as open, terminated, and classified, with reasons involving the presence of foreign material in product wells that could lead to inaccurate test results, including overestimation of sample values and potential discrepancies in classification outcomes when compared to FDA-cleared reference methods.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2025

    • 11 Dec 2025 Z-1301-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
    • 11 Dec 2025 Z-1302-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
    • 11 Dec 2025 Z-1303-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
    • 11 Dec 2025 Z-1304-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
    • 11 Dec 2025 Z-1305-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
    • 11 Dec 2025 Z-1306-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
    • 11 Dec 2025 Z-1307-2026 Class II Ongoing Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

  • 2010

    • 29 Jul 2010 Z-1606-2011 Unclassified (pre-2012) Terminated presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Fujirebio Diagnostics AB Molndal Vastra Gotaland · SE FEI 3027273565

About

Fujirebio is an R&D-driven company constantly developing new technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care.

From the manufacturer's own website. Source

What Fujirebio Diagnostics, Inc. makes

Fujirebio Diagnostics, Inc. manufactures laboratory instruments and associated software for in vitro diagnostics (IVD), including chemiluminescent immunoassay kits for detecting biomarkers like cytokeratin and Alzheimer’s disease-associated markers. It also produces controls and test kits for measuring 25-hydroxy vitamin D3, Treponema pallidum antibodies (IgG/IgM and total), cytomegalovirus (CMV) antibodies, and anti-Müllerian hormone (AMH). Wash solutions and sample reagents for diagnostic assays are part of its portfolio.

The company’s products are regulated under FDA classifications, including Class I and Class II devices, with submissions recorded in the 510(k) and UDI registries. Its diagnostics are listed in the United States, where the manufacturer is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
201 Great Valley Parkway, Malvern, PA, 19355
Website
fdi.com
Phone
1-877-861-7246
FDA FEI number
2521625
DUNS number
048524263