6 results
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51ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.
FDA Recall
Terminated
·Confirm Biosciences Inc·Product code QKO·January 29, 2021
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.
FDA Recall
Terminated
·Confirm Biosciences Inc·Product code QKO·January 29, 2021
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code OMN·October 7, 2025
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code NJR·October 7, 2025
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code OZN·December 5, 2025
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LCP·June 6, 2018