81 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 13, 2017
Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564. Quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·December 14, 2010
COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·March 2, 2011
COULTER HmX Hematology Analyzer with Autoloader Part number: 6605525, 6605526, 6605527 The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·March 2, 2011
Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·October 13, 2011
Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·October 13, 2011
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·June 26, 2017
Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader. Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000. Quantitative, automated, differential cell counters for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·December 14, 2010
COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number: 6705995, 6705996, 6705997/ Part number: 6705998, 67059999, 6706000. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·October 13, 2011
COULTER LH 500 Series Analyzer Part number: 178832, 178833, 178834 The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semiautomated reticulocyte analysis.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·March 2, 2011
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormality
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 13, 2017
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormality
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKZ·June 26, 2017
COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GGK·December 28, 2010
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
FDA Recall
Terminated
·Becton Dickinson and Company·Product code HMX·September 15, 2008
VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
FDA Recall
Terminated
·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
FDA Recall
Terminated
·Ellex iScience, Inc.·Product code HMX·January 11, 2018
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
FDA Recall
Terminated
·Bausch and Lomb, Incorporated·Product code HMX·November 15, 2012
Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
FDA Recall
Terminated
·Insight Instruments, Inc.·Product code HMX·March 15, 2013
S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place
FDA Recall
Terminated
·Becton Dickinson and Company·Product code HMX·December 17, 2010
VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
FDA Recall
Terminated
·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019