552 results
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42ms
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Sources: EU EUDAMED, US FDA
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Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
FDA Recall
Open, Classified
·Abbott Laboratories·Product code GKZ·September 18, 2025
ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.
FDA Recall
Terminated
·Abbott Laboratories·Product code JJE·February 26, 2009
Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·May 9, 2019
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code FPA·May 13, 2003
ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LCD·November 17, 2003
The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JQP·November 17, 2003
The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JQP·November 17, 2003
AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·June 6, 2002
The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·October 29, 2003
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Recall
Terminated
·Abbott Laboratories·Product code JKD·July 11, 2011
Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code MOI·March 4, 2003
Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCD·October 26, 2007
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code JJX·February 27, 2008
Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05 Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code JJX·February 27, 2008
ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code MMI·December 21, 2005
Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CEC--·December 15, 2003