FDA Device Recalls

Recalls / Firms / Abbott Laboratories

Abbott Laboratories

174 FDA device recalls on record.

DateClassProductReason
2025-11-13Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
2025-09-18Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Sof
2025-03-18Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Ver
2025-03-18Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Ver
2025-03-18Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Ver
2025-03-18Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Ver
2025-03-18Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Ver
2024-06-14Alinity hq Analyzer, REF: 09P68-01
2024-02-21ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
2023-10-19Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immu
2023-10-19Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sa
2023-10-19Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chem
2023-10-19ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARC
2023-05-30Alinity ci-series System Control Module, REF: 03R70-01
2022-11-24Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
2022-07-26ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
2022-06-09REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x
2022-06-09REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 3
2022-06-09REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x
2022-03-08ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for
2021-09-29ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 R
2021-09-29ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITEC
2021-07-26Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro dia
2021-06-10REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated
2021-06-10REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 0
2021-06-10REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 0
2021-06-10REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 0
2020-04-02Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell i
2020-04-01ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of pat
2020-04-01ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patien
2020-04-01ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of pat
2019-05-24ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of t
2019-05-24ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test pr
2019-05-22"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" -
2019-05-09Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number
2019-04-09ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensi
2019-04-09ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the c
2019-04-09Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use
2019-04-09ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the cal
2019-04-09ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration
2019-04-09ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the cali
2019-04-09ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive
2019-04-09ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calib
2019-04-09Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use
2019-02-20CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer
2017-04-18ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CM
2017-02-13CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parame
2016-10-11ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic
2016-03-24CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cl
2016-03-24The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
2015-06-11ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intende
2015-05-11Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It i
2014-07-22ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Ch
2014-04-30HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Cali
2014-02-12ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris
2014-02-12ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in B
2012-12-12Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x
2012-05-30ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25
2012-04-11ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic t
2011-10-07ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for
2011-07-11ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantit
2011-04-20ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualita
2011-03-15CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb)
2011-03-15CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb)
2011-03-15CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054
2011-03-15CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb)
2011-03-15CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics Division, Santa Cl
2011-03-15CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb)
2011-03-15CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb)
2010-10-15Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01
2010-09-30Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufacture
2010-09-13ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the
2010-09-07Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay
2010-05-27Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated M
2010-04-30IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coate
2010-04-16CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA.
2010-04-16CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste
2010-04-16CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA.
2010-04-16CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Rese
2010-04-05CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the
2010-03-23Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is man
2009-12-29CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analy
2009-11-30The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that a
2009-07-16CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Divi
2009-06-08CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA
2009-06-08CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematolog
2009-06-08CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, C
2009-04-24ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-R
2009-03-27Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Diagnostics D
2009-03-27Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured by Abbott Dia
2009-03-27Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manu
2009-03-27Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Man
2009-03-27Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader)
2009-02-26ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i S
2009-02-20Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbot
2009-02-18AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Divisi
2009-02-12Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufact
2009-01-19AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an ion captu
2009-01-19AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin is a Micro
2009-01-19AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle
2009-01-19AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a micropa
2009-01-19AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Troponin-I ADV
2009-01-19AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a
2008-12-10Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology
2008-11-17CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, aut
2008-09-05Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH
2008-08-25CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automate
2008-06-27Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to d
2008-06-16ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0
2008-06-02AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSY
2008-04-11CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification
2008-02-27Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C
2008-02-27Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6
2008-01-21AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories,
2008-01-15CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Ab
2007-12-19White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red
2007-10-01Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepat
2007-09-18ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for u
2007-07-25Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abb
2007-07-06ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Arc
2007-05-16CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical
2007-05-16Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software c
2007-05-11Abbott CELL-DYN 3700 Hematology Analyzer
2007-05-11Abbott CELL-DYN 3000 Hematology Analyzer
2007-05-11Abbott CELL-DYN 3500 Hematology Analyzer
2007-04-23AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Ab
2007-04-23AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abb
2007-04-23AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Laboratories,
2007-04-23AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott Laboratories,
2007-04-23AxSYM Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott Laboratories,
2007-04-23AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, A
2007-04-23AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbo
2007-04-23AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Laboratories, A
2007-04-23AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott Laboratori
2007-04-23AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott Laboratories,
2007-04-23AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laborator
2007-04-23AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories,
2007-04-23AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abb
2007-04-23AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, A
2007-04-23AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Ab
2007-04-23AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Ab
2007-04-23AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbot
2007-04-23AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abb
2007-02-19ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conju
2006-12-22CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73
2006-10-27Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN
2006-09-18Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology
2006-05-24i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufac
2006-04-17CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manuf
2005-12-16CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
2005-10-07Fleixiflo Quantum Enteral Pump.
2005-09-20Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(
2005-06-1810 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list
2005-03-16i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
2004-11-1218 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener Set (List #
2004-11-1210 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastner Set (list #5
2004-11-1220 French Flexiflo Inverta-PEG Pull Technique Basic Gastrostomy KIt with Roll-Tip Bumper (list # 520
2004-11-1218 French Ross Flexiflo Over the Guidewire Gastrostomy Basic Kit with T-Fasteners for Endoscopic Rem
2004-11-1220 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed Bumper fo
2004-11-1214 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Re
2004-11-1220 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 514
2004-11-1222 French Ross Versa-PEG Complete Gastrostomy Kit, an Over-the-Wire PEG Method Featuring Tube Remova
2004-11-1214 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Re
2004-11-1220 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopi
2004-11-1218 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller T-Fastener Set (list # 50190).
2004-11-1218 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (
2004-09-29CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott D
2004-05-12CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott
2004-02-24CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott
2003-04-01Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version
2003-04-01Gemstar Therapy Pain Management I. V. Infusion Pump, List #: 13150-04; 2.9 Software Version
2003-04-01Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version
2003-01-10Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List Number 01H77-01
2002-10-16Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01