• About the database
  • How to use the database
  • Download the data
  • FAQ
  • Credits
List view Cards view
  • Device 3309
  • Manufacturer 731
  • Event 124969
  • Implant 166
Cell-Dyn Emerald Cleanser
  • Model / Serial
  • Product Description
    IVD Other
  • Manufacturer
    Abbot Laboratories
  • 1 Event
    • Field Safety Notices about Cell-Dyn Emerald Cleanser
ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
  • Model / Serial
    3P24-25
  • Product Description
    DETERMINATION OF THE ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT
Architect Total PSA Reagent kit
  • Model / Serial
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTIC DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for Architect Total PSA Reagent kit
ARCHITECT SHBG REAGENT KIT
  • Model / Serial
  • Product Description
    CONTROL, CALIBRATION AND QUANTITATIVE DETERMINATION OF INSULIN, GLOBULINE IN THE BLOCKING OF SEXUAL HORMONES AND HORMONE PARATIROIDEA IN SERUM AND PLASMAHUMANS RESPECTIVELY.
  • Manufacturer
    ABBOTT LABORATORIES DIVISION DIAGNOSTICS || ABBOTT LABORATORIES JAPAN CO. LTD. || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Safety Alert for ARCHITECT SHBG REAGENT KIT
REALTIME HIV-1 QUALITATIVE AMPLIFICATION REAGENT KIT
  • Model / Serial
    Reference 04N66-90 Lots: All.
  • Product Description
    IN VITRO AMPLIFICATION TEST FOR QUALITATIVE LADETECTION OF NUCLEIC ACIDS OF THE HUMAN IMMUNODEFICIENCY VIRUS DET 1 (HIV - 1) IN PLASMA AND YANGAN SECA HUMAN SAMPLES.
  • Manufacturer
    ABBOTT GMBH & CO KG /ABBOTT MOLECULAR, INC || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for REALTIME HIV-1 QUALITATIVE AMPLIFICATION REAGENT KIT
ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
  • Model / Serial
    List Number (LN): 8L44-10, lot 54570LI00.
  • Product Description
    IMMUNOANALYSIS CHIMIOLUMINISCENTE DE MICROPARTICULAS (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES AGAINST THE ANTIGENOCORE OF HEPATITIS B VIRUS (ANTI HBC) HUMAN PLASMA AND PLASMA, INCLUDING POST-MORTEM RENEWED SAMPLES (WITHOUT CARDIAC TREATMENT).
  • Manufacturer
    ABBOTT GMBH & CO KG || Importer: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Safety Alert for ARCHITECT Anti- HBc II POSITIVE AND NEGATIVE CONTROL
Alinity I Processing Module ABBOTT
  • Model / Serial
    ALINITY CI-SERIES MODULE, all serials.
  • Product Description
    It is a fully automated immunoassay system that allows random and continuous access, as well as priority processing and automatic re-analysis using chemoluminescent micro-particle immunoassay technology. CMIA technology is used to determine the presence of antigens, antibodies and analytes in samples. The scalable design of the ALINITY I allows one or more sample processing modules, in multiple configurations, with a system control module to physically join together to form a single workstation.
  • Manufacturer
    Abbott Gmbh & Co. Kg
  • 2 Events
    • Safety Alert for Alinity I Processing Module ABBOTT
    • Safety Alert for Alinity I Processing Module ABBOTT
ARCHITECT Toxo IgM
  • Model / Serial
  • Product Description
    IMMUNOANALYSIS CHIMIOLUMINISCENT OF MICROPARTICLES (CMIA) FOR THE QUALITATIVE DETECTION OF ANTIBODIES IgM FRONT SToxoplasma gondii in SERUM AND HUMAN PLASMA.
  • Manufacturer
    ABBOTT GmbH&Co KG || Imported by: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Safety Alert for ARCHITECT Toxo IgM
ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT KIT
  • Model / Serial
    Reference: 2P13-28, lot: 10458UP00
  • Product Description
    DETERMINATION, CALIBRATION AND CONTROL OF THE TESTOSTERONE TEST IN SERUM AND PLASMAHUMAN
  • Manufacturer
    ABBOTT GMHBH & CO. KG || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for ARCHITECT 2ND GENERATION TESTOSTERONE REAGENT KIT
ARCHITECT STAT High Sensitive Troponin-I
  • Model / Serial
    Ref: 3P25-26 || Lot: 56940UI00
  • Product Description
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION.
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Safety Alert for ARCHITECT STAT High Sensitive Troponin-I
Alinity I HBsAg calibrators
  • Model / Serial
    08P0801 Lot:3313FN00
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for Alinity I HBsAg calibrators
ARCHITECT FREE T4 REAGENT
  • Model / Serial
  • Product Description
    QUANTITATIVE DETERMINATION OF TRIYODOTIRONIN T3 AND TORIXIN T4 IN SERUM AND PLASMA TO HUMANS.
  • Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION || Imported by: ABBOTT LABORATORIES DE || COLOMBIA S.A.
  • 1 Event
    • Safety Alert for ARCHITECT FREE T4 REAGENT
HEMOGLOBIN A1C CALIBRATORS
  • Model / Serial
  • Product Description
    Determination of the different analytes related to samples from the human organism.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Safety Alert for HEMOGLOBIN A1C CALIBRATORS
HEMOGLOBIN A1C REAGENT KIT
  • Model / Serial
    REF: 4P52-21 || LOTS: 50279UQ12, 50280UQ12, 50282UQ12, || 50613UQ02, 50614UQ02, 50615UQ02, 50884UQ04, || 50281UQ12, 50615UQ02, 51177UQ06, 50279UQ12, || 50280UQ12, 50031UQ10, 50007UQ10, 50281UQ12.
  • Product Description
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED WITH SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    ABBOTT LABORATORIES || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • 1 Event
    • Safety Alert for HEMOGLOBIN A1C REAGENT KIT
ALKALINE WASH SOLUTION (Solución Alcalina para lavado de cubetas de muestras)
  • Model / Serial
    Reference. 9D31-20 Lot. 45059UN14
  • Manufacturer
    Abbott Laboratories de Colombia S.A.
  • 1 Event
    • Safety Alert for ALKALINE WASH SOLUTION (Solución Alcalina para lavado de cubetas de muestras)
Multichem S Plus (Assayed) Level 2
  • Model / Serial
    Reference: 5P78-11. Lot13811132
  • Product Description
    Determination of analytes related to samples from the human organism
  • Manufacturer
    Abbott Laboratories de Colombia S.A. Brand. Technopath
  • 1 Event
    • Safety Alert for Multichem S Plus (Assayed) Level 2
ICT SERUM CALIBRATOR
  • Model / Serial
  • Product Description
    Quantitative determination of the related analytes in samples from the Human organism.
  • Manufacturer
    Abbott Laboratories Division Diagnostics Usa
  • 1 Event
    • Safety Alert for ICT SERUM CALIBRATOR
ARCHITECT INTACT PTH REAGENT KIT, ARCHITECT INTACT PTH CALIBRATORS, ARCHITECT INTACT CONTROLS.
  • Model / Serial
  • Product Description
    Control, calibration and quantitative determination of insulin, binding globulin of sex hormones and parathyroid hormone in human serum and plasma respectively.
  • Manufacturer
    Abbott Laboratories Division Diagnostics Usa.
  • 1 Event
    • Safety Alert for ARCHITECT INTACT PTH REAGENT KIT, ARCHITECT INTACT PTH CALIBRATORS, ARCHITECT INTACT CONTROLS.
Chemiluminescent immunoanalysis - Anti-HB II
  • Model / Serial
    Reference. 8L4425 Lots: 42072LI00, 42072LI01, 42253LI00, 42253LI01, Reference.8L44-30 Lots 42255LI00, 4225LI01, Reference. 8L44-35 Lot 42256LI00
  • Product Description
    Chemiluminescent immunoanalysis of macroparticles for the qualitative detection of antibodies against the CORE antigen of Hepatitis B virus (ANTI HBC) in serum and human plasma including samples collected POSTMORTEM
  • Manufacturer
    ABBOTT LABORATORIOS
  • 1 Event
    • Safety Alert for Chemiluminescent immunoanalysis - Anti-HB II
ABBOTT REAL TIME HIV 1 - REAGENT KIT
  • Model / Serial
    Lot: 462605
  • Product Description
    Quantitative determination of Human Immunodeficiency Virus type 1 in human plasma of patients infected by HIV 1
  • Manufacturer
    ABBOTT MOLECULAR INC || Importer: ABBOTT LABORATORIES DE COLOMBIA S.A
  • 1 Event
    • Safety Alert for ABBOTT REAL TIME HIV 1 - REAGENT KIT
REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
  • Model / Serial
  • Product Description
    REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
  • Manufacturer
    ABBOTT MOLECULAR INC. || Imported by: ABBOTT LABORATORIES DE COLOMBIA
  • 1 Event
    • Safety Alert for REAGENTS USED TO CARRY OUT CHEMISTRY TESTS.
Coronary Dilatation Catheter NC Trek
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Catheters for coronary dilatation are used for: 1. Balloon dilatation of the stenotic portion of a coronary artery from the stenosis of a bypass graft in order to improve myocardial perfusion. 2. Balloon dilatation of an occlusion in a coronary artery, in order to restore coronary flow in cases of myocardial infarction with ST-segment elevation. 3. Dilation with balloon of a stent after implanting it (balloon models from 2.00 mm to 5.00 mm only).
  • Manufacturer
    Abbott Vascular
  • 1 Event
    • Safety Alert for Coronary Dilatation Catheter NC Trek
Endovascular closure STARCLOSE SE ABBOTT
  • Model / Serial
  • Product Description
    Endovascular closure device designed for the closure of the femoral artery after percutaneous catheterization procedures.
  • Manufacturer
    Abbott Vascular
  • 1 Event
    • Safety Alert for Endovascular closure STARCLOSE SE ABBOTT
Abon - syphilis ultra rapid test (whole blood/serum/plasma)
  • Model / Serial
    ISY-U411 Lot: SYP8010030
  • Manufacturer
    ABON BIOPHARM || Importer: ALERE COLOMBIA S.A
  • 1 Event
    • Safety Alert for Abon - syphilis ultra rapid test (whole blood/serum/plasma)
Abon HCG
  • Model / Serial
    FHC-201. Lot HCG7070054.
  • Manufacturer
    ABON BIOPHARM || Importer: ALERE COLOMBIA S.A
  • 1 Event
    • Safety Alert for Abon HCG
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

  • FAQ
  • About the database
  • Contact us
  • Credits

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)