25 results
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52ms
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Sources: EU EUDAMED, US FDA
Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code JIX·September 6, 2006
Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code JMO·March 14, 2008
DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009
Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code CHH·November 10, 2010
Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code DKJ·December 5, 2006
DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.
FDA Recall
Terminated
·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009
VISERA CYSTO-NEPHRO VIDEOSCOPE
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FAJ·July 20, 2023
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
FDA Enforcement
Class II
·Terminated·Wako Life Sciences, Inc.·August 7, 2013
Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
FDA Recall
Terminated
·Wako Chemicals USA, Inc.·Product code DFC·January 30, 2012
Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
FDA Recall
Terminated
·Wako Chemicals, USA Inc·Product code MMY·July 6, 2006
COBAS® SARS-COV-2 & INFLUENZA A/B
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QLT·April 5, 2022
NEUVIZ 64 IN
FDA Adverse Event
Malfunction
·NEUSOFT MEDICAL SYSTEMS CO., LTD.·Product code JAK·October 29, 2019
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.
FDA Recall
Terminated
·Wako Life Sciences, Inc.·Product code DCF·April 30, 2013
Human Gesellschaft für Biochemica und Diagnostica mbH
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