552 results
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39ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JQP·October 25, 2007
Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·March 23, 2010
Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code JQW--·December 2, 2003
Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JQP·October 10, 2007
IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code MLM·November 13, 2003
CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003
CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code LID·December 14, 2001
Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code LOM--·April 7, 2003
ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DJR--·December 5, 2003
TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DJR--·December 5, 2003
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003
TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DKJ--·December 5, 2003
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·October 15, 2010
IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003
TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DIC--·December 5, 2003
IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LFX·July 22, 2003
TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code JFT·February 16, 2004
Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code JLS·March 31, 2003
IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003