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Abbott Laboratories

140 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 recall (Z-0961-2026)Abbott Laboratories2025-12-18
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09 recall (Z-0489-2026)Abbott Laboratories2025-11-12
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Softw recall (Z-1652-2025)Abbott Laboratories2025-04-22
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Softw recall (Z-1653-2025)Abbott Laboratories2025-04-22
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Softw recall (Z-1654-2025)Abbott Laboratories2025-04-22
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Softw recall (Z-1655-2025)Abbott Laboratories2025-04-22
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Softw recall (Z-1656-2025)Abbott Laboratories2025-04-22
Alinity hq Analyzer, REF: 09P68-01 recall (Z-2681-2024)Abbott Laboratories2024-08-16
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. recall (Z-1476-2024)Abbott Laboratories2024-04-04
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automa recall (Z-0680-2024)Abbott Laboratories2024-01-09
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automa recall (Z-0681-2024)Abbott Laboratories2024-01-09
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Ab recall (Z-0682-2024)Abbott Laboratories2024-01-09
Alinity ci-series System Control Module, REF: 03R70-01 recall (Z-0613-2024)Abbott Laboratories2023-12-22
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, M recall (Z-0604-2024)Abbott Laboratories2023-12-21
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction recall (Z-0958-2023)Abbott Laboratories2023-01-17
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS recall (Z-2251-2020)Abbott Laboratories2020-06-03
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immuno recall (Z-2613-2017)Abbott Laboratories2017-05-03
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a mult recall (Z-1438-2017)Abbott Laboratories2017-03-09
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation recall (Z-0379-2017)Abbott Laboratories2016-11-09
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Em recall (Z-1522-2016)Abbott Laboratories2016-04-19
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is recall (Z-2202-2015)Abbott Laboratories2015-07-22
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium recall (Z-1932-2015)Abbott Laboratories2015-06-27
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analy recall (Z-1725-2015)Abbott Laboratories2015-06-08
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL recall (Z-0135-2015)Abbott Laboratories2014-10-24
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contain recall (Z-1671-2014)Abbott Laboratories2014-05-29
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic pep recall (Z-1672-2014)Abbott Laboratories2014-05-29
Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U recall (Z-0698-2013)Abbott Laboratories2013-01-23
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests recall (Z-1904-2012)Abbott Laboratories2012-06-29
ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro di recall (Z-1509-2012)Abbott Laboratories2012-05-10
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay recall (Z-0162-2012)Abbott Laboratories2011-11-04
ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for t recall (Z-2413-2011)Abbott Laboratories2011-06-06
CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyze recall (Z-2014-2011)Abbott Laboratories2011-04-29
CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyze recall (Z-2015-2011)Abbott Laboratories2011-04-29
CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyze recall (Z-2016-2011)Abbott Laboratories2011-04-29
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyze recall (Z-2017-2011)Abbott Laboratories2011-04-29
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyze recall (Z-2018-2011)Abbott Laboratories2011-04-29
CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics Division, recall (Z-2019-2011)Abbott Laboratories2011-04-29
CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054 recall (Z-2020-2011)Abbott Laboratories2011-04-29
Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The prod recall (Z-1733-2011)Abbott Laboratories2011-03-18
Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is ma recall (Z-1668-2011)Abbott Laboratories2011-03-17
The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are compone recall (Z-1698-2011)Abbott Laboratories2011-03-17
Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Samp recall (Z-1701-2011)Abbott Laboratories2011-03-17
Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loa recall (Z-1702-2011)Abbott Laboratories2011-03-17
Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loa recall (Z-1703-2011)Abbott Laboratories2011-03-17
Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured by recall (Z-1902-2011)Abbott Laboratories2011-03-17
Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Dia recall (Z-2752-2011)Abbott Laboratories2011-03-17
CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hemato recall (Z-1623-2011)Abbott Laboratories2011-03-11
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: recall (Z-1094-2011)Abbott Laboratories2011-02-10
ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMI recall (Z-0629-2011)Abbott Laboratories2010-12-16
Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle im recall (Z-0068-2011)Abbott Laboratories2010-10-15
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) u recall (Z-2421-2010)Abbott Laboratories2010-09-14
CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Cl recall (Z-2350-2010)Abbott Laboratories2010-09-02
CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Cl recall (Z-2351-2010)Abbott Laboratories2010-09-02
CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. W recall (Z-2352-2010)Abbott Laboratories2010-09-02
CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, C recall (Z-2353-2010)Abbott Laboratories2010-09-02
IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Anti recall (Z-2171-2010)Abbott Laboratories2010-08-03
Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimu recall (Z-2172-2010)Abbott Laboratories2010-08-03
CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa recall (Z-1628-2010)Abbott Laboratories2010-05-20
CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott recall (Z-1629-2010)Abbott Laboratories2010-05-20
CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa C recall (Z-1630-2010)Abbott Laboratories2010-05-20
CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnos recall (Z-0065-2010)Abbott Laboratories2009-10-19
AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnost recall (Z-2317-2009)Abbott Laboratories2009-09-30
ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System recall (Z-2325-2009)Abbott Laboratories2009-09-30
Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM Sys recall (Z-2222-2009)Abbott Laboratories2009-09-18
ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARC recall (Z-1392-2009)Abbott Laboratories2009-05-27
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01 recall (Z-1398-2009)Abbott Laboratories2009-05-22
Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated recall (Z-1069-2009)Abbott Laboratories2009-04-23
AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a mic recall (Z-1046-2009)Abbott Laboratories2009-04-15
AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG recall (Z-1047-2009)Abbott Laboratories2009-04-15
AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is recall (Z-1048-2009)Abbott Laboratories2009-04-15
AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an recall (Z-1049-2009)Abbott Laboratories2009-04-15
AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Myoglobin recall (Z-1050-2009)Abbott Laboratories2009-04-15
AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Tropo recall (Z-1051-2009)Abbott Laboratories2009-04-15
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-param recall (Z-1064-2009)Abbott Laboratories2009-04-10
CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, recall (Z-0306-2009)Abbott Laboratories2008-11-21
Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vi recall (Z-0216-2009)Abbott Laboratories2008-11-13
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum recall (Z-2305-2008)Abbott Laboratories2008-09-20
ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and V recall (Z-2239-2008)Abbott Laboratories2008-09-19
AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 T recall (Z-2175-2008)Abbott Laboratories2008-09-16
CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Spe recall (Z-2139-2008)Abbott Laboratories2008-08-21
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed recall (Z-1569-2008)Abbott Laboratories2008-07-31
Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassaye recall (Z-1570-2008)Abbott Laboratories2008-07-31
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Sy recall (Z-1103-2008)Abbott Laboratories2008-05-14
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La bo recall (Z-1462-2008)Abbott Laboratories2008-05-14
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Ana recall (Z-1165-2008)Abbott Laboratories2008-04-24
Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators an recall (Z-0455-2008)Abbott Laboratories2008-03-13
Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibod recall (Z-0127-2008)Abbott Laboratories2008-01-24
ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 2 recall (Z-0299-2008)Abbott Laboratories2008-01-09
Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H recall (Z-0301-2008)Abbott Laboratories2008-01-04
ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bot recall (Z-1222-2007)Abbott Laboratories2007-09-18
Abbott CELL-DYN 3000 Hematology Analyzer recall (Z-1198-2007)Abbott Laboratories2007-08-29
Abbott CELL-DYN 3500 Hematology Analyzer recall (Z-1199-2007)Abbott Laboratories2007-08-29
Abbott CELL-DYN 3700 Hematology Analyzer recall (Z-1200-2007)Abbott Laboratories2007-08-29
CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled recall (Z-1170-2007)Abbott Laboratories2007-08-18
Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, recall (Z-1171-2007)Abbott Laboratories2007-08-18
AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott recall (Z-1023-2007)Abbott Laboratories2007-07-11
AxSYM Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott Lab recall (Z-1024-2007)Abbott Laboratories2007-07-11
AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott recall (Z-1025-2007)Abbott Laboratories2007-07-11
AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Labor recall (Z-1026-2007)Abbott Laboratories2007-07-11
AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Labo recall (Z-1027-2007)Abbott Laboratories2007-07-11
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