2 results
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38ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
FDA Recall
Completed
·Luminex Corporation·Product code PEN·April 16, 2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
FDA Enforcement
Class II
·Completed·Luminex Corporation·June 11, 2025