127 results
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8ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Sendx Medical Inc·Product code CHL·February 20, 2009
ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code JJI·January 2, 2007
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712. Assayed quality control material for use with the Cholestech LDX System.
FDA Recall
Terminated
·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010
Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM Rubella Virus IgM Toxoplasma gondii IgM
FDA Recall
Terminated
·Bio-rad Laboratories, Inc.·Product code JJY·April 15, 2013
Randox Liquid Cardiac Controls Catalogue Number CQ5051
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·October 4, 2019
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
FDA Recall
Terminated
·Randox Laboratories·Product code JJY·August 11, 2017
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
FDA Recall
Terminated
·Randox Laboratories·Product code JJY·August 11, 2017
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·October 4, 2019
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·November 2, 2020
Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control material for use with the Cholestech LDX System.
FDA Recall
Terminated
·Biosite Inc Dba Innovacon Inc.·Product code JJY·October 6, 2010
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
FDA Recall
Terminated
·Horiba Instruments, Inc dba Horiba Medical·Product code JJY·November 21, 2013
MAS Omni Immune PRO Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
Liquid Cardiac Control CQ5053
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JJY·August 8, 2017
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
FDA Recall
Terminated
·Medtest Holdings, Inc.·Product code JJY·May 15, 2014
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·February 7, 2019
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code JJY·October 12, 2016
Liquid Cardiac Control, CQ5053
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·October 2, 2018
Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to assist in monitoring test performance.
FDA Recall
Terminated
·Biosite Inc·Product code jjy·February 6, 2009
ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code JJY·December 4, 2009
Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code JJY·December 4, 2009