44 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cytomics MXP Software, Version 1.0, Part No. 623688.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKL·February 13, 2004
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code GKL·June 26, 2013
COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKL·April 18, 2007
CXP software, Part No. 623560, version 1.0
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKL·February 13, 2004
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code GKL·March 18, 2016
Coulter GEN's 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 semi-automated reticulocyte analysis.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GKL·January 31, 2011
ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
FDA Recall
Terminated
·Bayer Healthcare, LLC (Diagnostics Division)·Product code GKL·March 16, 2006
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKL·December 19, 2014
GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.
FDA Recall
Terminated
·Advanced Instruments, LLC·Product code GKL·February 7, 2018
Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKL·February 13, 2004
Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM). Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
FDA Recall
Terminated
·Biomet Sports Medicine·Product code MBI·April 24, 2008
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
FDA Enforcement
Class II
·Terminated·Richard-Allan Scientific Company·May 27, 2015
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·December 5, 2018
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·Product code KPO·June 1, 2022
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 13, 2022
Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
FDA Enforcement
Class III
·Terminated·Fresenius Medical Care Holdings, Inc.·January 23, 2013
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LEH·April 30, 2007
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LEG·April 30, 2007