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Name Classification Manufacturer Risk Class Country Source
continuous glucose monitoring system DexCom PLATINUM G4 and DexCom G5 Clinical Chemistry and Clinical Toxicology Devices Dexcom, Inc Colombia INVIMA
Leadcare blood lead test kit/Leadcare II blood lead test kit Clinical Chemistry and Clinical Toxicology Devices ESA BIOSCIENCES INC || Imported by: ANNAR DIAGNOSTICA || IMPORT S.A S Colombia INVIMA
strips to measure glucose (glucose Nova Max) Clinical Chemistry and Clinical Toxicology Devices Nova Biomedical Colombia INVIMA
SPOTCHEM II PANEL-1 / SPOTCHEM II Glucose Reagent Test Strip Clinical Chemistry and Clinical Toxicology Devices ARKRAY FACTORY/BIOSYSTEMS S.A. Colombia INVIMA
Jaundice Meter Clinical Chemistry and Clinical Toxicology Devices Draeger Medical Systems, Inc. || Konica Minolta Inc Colombia INVIMA
Onetouch®pro - glycaemic self-management system intended for home and ambulatory use Clinical Chemistry and Clinical Toxicology Devices LifeScanEurope - Division of Cilag GmbH Croatia AMPMDC
Draeger Jaundice Meter JM 103 Clinical Chemistry and Clinical Toxicology Devices Draeger Medical Systems Inc New Zealand NZMMDSA
dexcom g4 platinum receiver Clinical Chemistry and Clinical Toxicology Devices DEXCOM Italy MSHM
leadcare / leadcareii / leadcare ultra / leadcare plus Clinical Chemistry and Clinical Toxicology Devices ICHOR TECHNOLOGIES LTD Italy MSHM
bd vacutainer edta & bd vacutainer lithium heparin tubes Clinical Chemistry and Clinical Toxicology Devices BECTON DICKINSON AND COMPANY Italy MSHM
OneTouch Verio IQ Blood Glucose Meters Clinical Chemistry and Clinical Toxicology Devices LifeScan France ANSM
VITROS TROPONINE I Clinical Chemistry and Clinical Toxicology Devices ORTHO CLINICAL DIAGNOSTICS France ANSM
Accu-Chek Performa Test Strips for Blood Glucose Meters Clinical Chemistry and Clinical Toxicology Devices Roche Diagnostics France ANSM
Device Recall SoftPath Clinical Chemistry and Clinical Toxicology Devices SCC Soft Computer 1 United States USFDA
Device Recall UniStrip1 Clinical Chemistry and Clinical Toxicology Devices Unistrip Technologies LLC 2 United States USFDA
Device Recall VITROS 3600 Immunodiagnostic System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States USFDA
Device Recall VITROS 4600 Chemistry System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States USFDA
Device Recall VITROS 5600 Integrated System Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics 1 United States USFDA
Device Recall Dimension Vista Myoglobin Calibrator Clinical Chemistry and Clinical Toxicology Devices Siemens Healthcare Diagnostics, Inc. 2 United States USFDA
Device Recall RTH8 Rotor Clinical Chemistry and Clinical Toxicology Devices Iris Diagnostics 1 United States USFDA
Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test Clinical Chemistry and Clinical Toxicology Devices Express Diagnostics Int'l., Inc. 3 United States USFDA
Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6 Clinical Chemistry and Clinical Toxicology Devices Roche Diagnostics Operations, Inc. 2 United States USFDA
Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1 Clinical Chemistry and Clinical Toxicology Devices SCC Soft Computer 1 United States USFDA
Device Recall Beckman Coulter, Lipase Assay Clinical Chemistry and Clinical Toxicology Devices Beckman Coulter Inc. 1 United States USFDA
Device Recall Beckman Coulter, Uric Acid Assay Clinical Chemistry and Clinical Toxicology Devices Beckman Coulter Inc. 1 United States USFDA