4 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·April 4, 2018
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NQX·October 27, 2017
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 17, 2021
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·January 6, 2021