9 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Recall
Terminated
·Oxford Immunotec·Product code OJN·July 16, 2020
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Recall
Terminated
·Oxford Immunotec·Product code OJN·July 16, 2020
AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code LDM·November 17, 2003
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LFM·June 12, 2013
Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
FDA Recall
Terminated
·Applied Biotech Inc·Product code LCM·May 31, 2005
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LFM·November 14, 2012
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LFM·June 28, 2012