6 results
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14ms
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Sources: EU EUDAMED, US FDA
ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code LFH·November 17, 2003
Alere iScreen Dx Urine Drug Screen Card
FDA Recall
Terminated
·Ameditech Inc·Product code LFH·December 15, 2017
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
FDA Recall
Terminated
·Ameditech Inc·Product code LFH·June 26, 2017
ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JFH·March 5, 2018
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code DFH·May 20, 2021
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code DFH·November 18, 2020