11 results
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67ms
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Sources: EU EUDAMED, US FDA
COULTER LIN-X LINEARITY CONTROL
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JPK·September 30, 2011
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Recall
Terminated
·Heartware Inc·Product code DSQ·December 27, 2012
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code CGA·April 7, 2014
"***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi Industrial Estate, Tambon Bowin, Amphur Sriracha, Chonburi 20230, Thailand***Victus Inc. 4918 SW 74 Court 33155 44400***" Packed 24 units per case. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
FDA Recall
Terminated
·Victus, Inc.·Product code MEB·September 20, 2011
CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.
FDA Recall
Terminated
·Cardiopulmonary Instrumentation, Inc·Product code FPO·February 17, 2011
Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
FDA Recall
Terminated
·Cordis Corporation·Product code DYB·October 15, 2009
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
FDA Recall
Terminated
·Diamedix Corporation·Product code LLL·June 8, 2011
UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·October 20, 2010
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·October 20, 2010
COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): All Serial Numbers The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·February 23, 2011
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·September 24, 2013