Abbott Laboratories
Santa Clara, CA
This page shows every FDA and USDA recall linked to Abbott Laboratories. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
56
Total Recalls
2002
First Recall
2025
Most Recent
Brand Name: Alinity hq Analyzer
Product Name: Alinity hq Analyzer
Model/Catalog Number: 09P68-01
Software Vers...
Nov 12, 2025
· Device
Open, Classified
Alinity hq Analyzer, REF: 09P68-01
Aug 16, 2024
· Device
Open, Classified
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01....
May 9, 2019
· Device
Terminated
CELL-DYN Emerald analyzer, REF 09H39-01.
The CELL-DYN Emerald is an automated hematology analyzer intended f...
Feb 20, 2019
· Device
Terminated
CELL-DYN Ruby System:
List Number: 08H6701;
Hematology: The CELL-DYN Ruby System is a multi-parameter automa...
Mar 9, 2017
· Device
Terminated
CELL-DYN Emerald Cleaner, product number 09H46-02.
960mL.
IVD;
Hematology:
The CELL-DYN Emerald Cleaner is d...
Apr 19, 2016
· Device
Terminated
CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb).
Abbott...
Apr 29, 2011
· Device
Terminated
CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb).
Abbott...
Apr 29, 2011
· Device
Terminated
CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb).
Abbott...
Apr 29, 2011
· Device
Terminated
CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer.
Abbott Diagnostics Division, Santa Clara, CA 05...
Apr 29, 2011
· Device
Terminated
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb).
Abbott...
Apr 29, 2011
· Device
Terminated
CELL-DYN Sheer Valve Assembly Driver
Abbott Diagnostics Division, Santa Clara, CA 05054
Apr 29, 2011
· Device
Terminated
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb).
Abbott...
Apr 29, 2011
· Device
Terminated
Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured...
Mar 18, 2011
· Device
Terminated
The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on...
Mar 17, 2011
· Device
Terminated
Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Manufactured...
Mar 17, 2011
· Device
Terminated
Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02,
Product is manufactured and dist...
Mar 17, 2011
· Device
Terminated
Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured by Abbott Diagnostics D...
Mar 17, 2011
· Device
Terminated
Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Diagnostics Division, S...
Mar 17, 2011
· Device
Terminated
Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader), Manufac...
Mar 17, 2011
· Device
Terminated
Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured b...
Mar 17, 2011
· Device
Terminated
CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List...
Mar 11, 2011
· Device
Terminated
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System;
List Number: 09H39-01; Field Re...
Feb 10, 2011
· Device
Terminated
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn...
Sep 14, 2010
· Device
Terminated
CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir...
Sep 2, 2010
· Device
Terminated
CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Rese...
Sep 2, 2010
· Device
Terminated
CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Rese...
Sep 2, 2010
· Device
Terminated
CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Asse...
Sep 2, 2010
· Device
Terminated
CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa C...
May 20, 2010
· Device
Terminated
CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA
May 20, 2010
· Device
Terminated
CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA
May 20, 2010
· Device
Terminated
CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Sant...
Oct 19, 2009
· Device
Terminated
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Ab...
May 22, 2009
· Device
Terminated
Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer,...
Apr 23, 2009
· Device
Terminated
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01
The CELL-DYN Ruby is a multi-parameter, automated hem...
Apr 10, 2009
· Device
Terminated
CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03
A multi- parameter, automated hematolo...
Nov 21, 2008
· Device
Terminated
CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott D...
Aug 21, 2008
· Device
Terminated
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysi...
May 14, 2008
· Device
Terminated
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs,...
Apr 24, 2008
· Device
Terminated
Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Contro...
Mar 13, 2008
· Device
Terminated
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Labora...
Jan 4, 2008
· Device
Terminated
Abbott CELL-DYN 3700 Hematology Analyzer
Aug 29, 2007
· Device
Terminated
Abbott CELL-DYN 3500 Hematology Analyzer
Aug 29, 2007
· Device
Terminated
Abbott CELL-DYN 3000 Hematology Analyzer
Aug 29, 2007
· Device
Terminated
CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for...
Aug 18, 2007
· Device
Terminated
Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled...
Aug 18, 2007
· Device
Terminated
CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by...
Apr 3, 2007
· Device
Terminated
CELL-DYN 3200 Diluent/Sheath Reagent,
List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics...
Apr 3, 2007
· Device
Terminated
CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by:
Abbott Diagnosti...
Mar 17, 2007
· Device
Terminated
CELL-DYN 4000 Diluent/Sheath Reagent,
List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostic...
Mar 16, 2007
· Device
Terminated