7 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Iron Deficiency Test (ferritin)
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·January 24, 2024
AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 6, 2021
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·March 21, 2018
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·December 30, 2015