Company · US
Abbott Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
890510(k) clearances (2 in 12 months)
267recalls (2 in 12 months)
209recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 78 |
| FRN | Pump, Infusion | 71 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 70 |
| FPA | Set, Administration, Intravascular | 30 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 23 |
| CIG | Diazo Colorimetry, Bilirubin | 16 |
| JIT | Calibrator, Secondary | 16 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 15 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 14 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 13 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 13 |
| LNO | 13 | |
| NBW | System, Test, Blood Glucose, Over The Counter | 12 |
| FPB | Filter, Infusion Line | 11 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 11 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 10 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 10 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 10 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 9 |
| DKZ | Enzyme Immunoassay, Amphetamine | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K262156 | Anti-HCV Next Abbott Laboratories | MZO |
| Apr 28, 2026 | K252424 | Anti-HCV Next Abbott Laboratories | MZO |
| Jul 9, 2025 | K243500 | ARCHITECT iGentamicin Abbott Laboratories | LCD |
| Jun 20, 2025 | K243168 | Alinity i Rubella IgG Abbott Laboratories | LFX |
| Feb 20, 2025 | K243283 | Alinity h-series System Abbott Laboratories | GKZ |
| Aug 30, 2024 | K233932 | Alinity i Toxo IgM Abbott Laboratories | LGD |
| Sep 29, 2023 | K232669 | TBI Abbott Laboratories | QAT |
| Aug 10, 2023 | K222850 | HAVAb IgG II Abbott Laboratories | LOL |
| Aug 4, 2023 | K220031 | Alinity h-series System Abbott Laboratories | GKZ |
| Jul 14, 2023 | K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System Abbott Laboratories | GJS |
| Jun 5, 2023 | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track Abbott Laboratories | DHA |
| May 19, 2023 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series Abbott Laboratories | DHA |
| Mar 2, 2023 | K223602 | Traumatic brain injury (TBI) test Abbott Laboratories | QAT |
| Oct 27, 2022 | K220949 | Architect CMV IgG Abbott Laboratories | LFZ |
| May 19, 2022 | K210596 | ARCHITECT Toxo IgG Abbott Laboratories | LGD |
| Mar 10, 2022 | K213486 | GLP systems Track Abbott Laboratories | JGS |
| Jan 8, 2021 | K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System Abbott Laboratories | QAT |
| Mar 15, 2019 | K190294 | CELL-DYN Emerald 22 AL System Abbott Laboratories | GKZ |
| Sep 12, 2018 | K181748 | Magnesium Abbott Laboratories | JGJ |
| May 18, 2018 | K173294 | Magnesium Abbott Laboratories | JGJ |
| Oct 27, 2017 | K173122 | Abbott Architect Free T4 Abbott Laboratories | CEC |
| Oct 24, 2017 | K170320 | Alinity c ICT Sample Diluent Abbott Laboratories | CGZ |
| Oct 23, 2017 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System Abbott Laboratories | DHA |
| Oct 19, 2017 | K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM Abbott Laboratories | CFR |
| Aug 22, 2017 | K163342 | i-STAT Hematocrit test with i-STAT Alinity System Abbott Laboratories | JPI |
| Feb 15, 2017 | K170160 | Abbott ARCHITECT Free T3 Abbott Laboratories | JIT |
| Aug 12, 2016 | K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls Abbott Laboratories | MRG |
| Jun 15, 2016 | K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control Abbott Laboratories | LIP |
| Dec 17, 2015 | K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem Abbott Laboratories | NBW |
| Dec 17, 2015 | K152155 | ARCHITECT 2nd Generation Testosterone Abbott Laboratories | CDZ |
| Jul 10, 2015 | K151566 | Abbott ARCHITECT Total T4 Calibrators Abbott Laboratories | JIT |
| Jun 5, 2015 | K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System Abbott Laboratories | NBW |
| Jun 5, 2015 | K150332 | FreeStyle Lite Blood Glucose Monitoring System Abbott Laboratories | NBW |
| May 22, 2015 | K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls Abbott Laboratories | PDJ |
| Apr 2, 2015 | K150510 | Total Bilirubin Abbott Laboratories | CIG |
| Feb 28, 2014 | K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS Abbott Laboratories | PDJ |
| Apr 5, 2013 | K123089 | FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 Abbott Laboratories | NBW |
| Feb 1, 2013 | K121985 | ARCHITECT TOTAL BILIRUBIN Abbott Laboratories | CIG |
| Jan 14, 2013 | K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR Abbott Laboratories | JIX |
| Dec 21, 2012 | K121003 | ABBOTT PLEX-ID FLU ASSAY Abbott Laboratories | OCC |
| Nov 27, 2012 | K123379 | ABBOTT ARCHITECT FREE T4 Abbott Laboratories | CEC |
| Sep 11, 2012 | K120009 | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) Abbott Laboratories | CDZ |
| Jun 28, 2012 | K113704 | ARCHITECT HAVAB-G Abbott Laboratories | LOL |
| May 17, 2012 | K121314 | ARCHITECT B12 Abbott Laboratories | CDD |
| Apr 20, 2012 | K113719 | SAFETY SCREW CONNECTOR Abbott Laboratories | KNT |
| Feb 16, 2012 | K111874 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS Abbott Laboratories | LFR |
| Dec 22, 2011 | K110381 | CELL-DYN EMERALD 22 SYSTEM Abbott Laboratories | GKZ |
| Oct 14, 2011 | K103627 | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS Abbott Laboratories | KLT |
| Oct 6, 2011 | K110579 | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS Abbott Laboratories | CDD |
| Jun 10, 2011 | K111023 | ABBOTT ARCHITECT LH CALIBRATORS Abbott Laboratories | JIT |
Newest 50 of 890.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Abbott Laboratories Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Open, Classified |
JJE | K170316 K170317 |
| Nov 12, 2025 | Abbott Laboratories 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 Analy Open, Classified |
GKZ | K220031 K243283 |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 04U42-84
Software Version: All software versions
Product Description: CELL-DYN Ruby Open, Classified |
GKZ | K061667 |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-13
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | K061667 |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-10
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | K061667 |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-03
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | K061667 |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-01
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | K061667 |
| Aug 16, 2024 | Abbott Laboratories Alinity hq Analyzer, REF: 09P68-01 Open, Classified |
GKZ | K220031 |
| Apr 4, 2024 | Abbott Laboratories ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. Open, Classified |
DDR | K042924 |
| Jan 9, 2024 | Abbott Laboratories ARCHITECT c4000 Processing Module REF:
02P24-01
02P24-02
02P24-40
01R24-56
01R25-56
The Abbott ARCHITECT c4000 Processing Module is designed to perform automated
chemistry tests, utilizing photometr Open, Classified |
JJE | None listed |
| Jan 9, 2024 | Abbott Laboratories Alinity c Processing Module REF 03R67-01
The Alinity c Processing Module is a fully automated chemistry analyzer allowing random
and continuous access, as well as priority and automated retest proce Open, Classified |
JJE | None listed |
| Jan 9, 2024 | Abbott Laboratories Alinity i Processing Module REF 03R65-01
The Alinity i Processing Module is a fully automated immunoassay analyzer allowing
random and continuous access, as well as priority and automated retest pro Open, Classified |
JJE | None listed |
| Dec 22, 2023 | Abbott Laboratories Alinity ci-series System Control Module, REF: 03R70-01 Open, Classified |
JJE | None listed |
| Dec 21, 2023 | Abbott Laboratories Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer. Open, Classified |
GKZ | K051215 K061667 |
| Jan 17, 2023 | Abbott Laboratories Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels Open, Classified |
DHA | K170317 |
| Jul 26, 2022 | Abbott Laboratories ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 Open, Classified |
MMI | K041192 |
| Jun 9, 2022 | Abbott Laboratories REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL Open, Classified |
PDJ | None listed |
| Jun 9, 2022 | Abbott Laboratories REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL Open, Classified |
PDJ | K130255 |
| Jun 9, 2022 | Abbott Laboratories REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL Open, Classified |
PDJ | K130255 K140654 |
| Mar 8, 2022 | Abbott Laboratories ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01
The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitativ Open, Classified |
JIS | K042924 |
| Feb 3, 2022 | Abbott Laboratories, Inc Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479
The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, full Open, Classified |
MZA | None listed |
| Sep 29, 2021 | Abbott Laboratories ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25;
ARCHITECT c8000 REF 01G06-11/1G06;
ARCHITECT c16000 REF 03L77-01/3L77; Open, Classified |
JJE | K983212 |
| Sep 29, 2021 | Abbott Laboratories ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87;
ARCHITECT i2000SR REF 03M74-02/3M74;
ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Open, Classified |
JJE | K983212 |
| Jul 26, 2021 | Abbott Laboratories Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01 Open, Classified |
JJE | None listed |
| Jul 12, 2021 | Abbott Laboratories, Inc Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and re Open, Classified |
MZA | None listed |
| Jun 10, 2021 | Abbott Laboratories REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866 Open, Classified |
CKA | None listed |
| Jun 10, 2021 | Abbott Laboratories REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866 Open, Classified |
CKA | None listed |
| Jun 10, 2021 | Abbott Laboratories REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859 Open, Classified |
CKA | None listed |
| Jun 10, 2021 | Abbott Laboratories REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569 Open, Classified |
CKA | None listed |
| Jun 3, 2020 | Abbott Laboratories Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. T Terminated |
CEM | K093318 |
| Apr 1, 2020 | Abbott Laboratories ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Terminated |
JKD | None listed |
| Apr 1, 2020 | Abbott Laboratories ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Terminated |
JJX | None listed |
| Apr 1, 2020 | Abbott Laboratories ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. Terminated |
JIT | None listed |
| May 24, 2019 | Abbott Laboratories ARCHITECT BNP Controls
Ptoduct Usage:
The ARCHITECT BNP Controls are for the estimation of test precision and the detection of
systematic analytical deviations of the ARCHITECT iSystem (reagents, ca Terminated |
JJX | K060964 |
| May 24, 2019 | Abbott Laboratories ARCHITECT BNP Calibrators
Ptoduct Usage:
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide Terminated |
JIT | K060964 |
| May 22, 2019 | Abbott Laboratories "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay. Terminated |
JIT | K140654 |
| May 9, 2019 | Abbott Laboratories 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. Terminated |
GKZ | K081495 |
| May 1, 2019 | Abbott Laboratories, Inc ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a c Terminated |
JJE | K980367 |
| Apr 9, 2019 | Abbott Laboratories Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th Terminated |
JJY | K132751 |
| Apr 9, 2019 | Abbott Laboratories Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th Terminated |
JJY | K132751 |
| Apr 9, 2019 | Abbott Laboratories ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of th Terminated |
JIT | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic an Terminated |
JIT | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analyt Terminated |
JIT | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in hu Terminated |
JIT | K063232 |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human Terminated |
JJX | K063232 |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (H Terminated |
JIT | K121842 |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human Terminated |
JIT | K070822 |
| Feb 20, 2019 | Abbott Laboratories CELL-DYN Emerald analyzer, REF 09H39-01.
The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory. Terminated |
GKZ | K081495 |
| Jan 2, 2019 | Abbott Laboratories, Inc ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31
The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine. Terminated |
JGJ | K981791 |
| Sep 7, 2018 | Abbott Laboratories, Inc APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product, Terminated |
JQP | K093318 |
Newest 50 of 267.