Data / Medical devices / United States / Abbott Laboratories
Abbott Laboratories: FDA-registered device maker in Irving, TX, United States, 54 510(k) clearances
Abbott Laboratories is registered with the FDA (registration 3016438761) in Irving, TX, United States. It lists 71 device types. The FDA files 54 510(k) clearances under its listings, the newest dated February 20, 2025. 10 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016438761
- Address
- 1915 Hurd Drive, Irving, TX, United States, 75038
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 13, 1977
- Registered through
- 2027
- Brand names listed
- 20X SSC, 500g, ACE Calibrator (LN 06U8201), ACE Calibrator (LN 06U8601), ACE Control (LN 06U8210), ACE Control (LN 06U8610), ACID PHOSPHATASE (ACP) (LN 9D87-21), ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42), ACTIVATED ASPARTATE AMINOTRANSFERASE (LN 8L91-21, 8L91-41) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2025 | K243283 | Alinity h-series System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 4, 2023 | K220031 | Alinity h-series System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 19, 2023 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| March 15, 2019 | K190294 | CELL-DYN Emerald 22 AL System | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 12, 2018 | K181748 | Magnesium | JGJ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 24, 2017 | K170320 | Alinity c ICT Sample Diluent | CGZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 23, 2017 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 19, 2017 | K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | CFR | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 22, 2015 | K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | PDJ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 2, 2015 | K150510 | Total Bilirubin | CIG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 28, 2014 | K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | PDJ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 1, 2013 | K121985 | ARCHITECT TOTAL BILIRUBIN | CIG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 14, 2013 | K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | JIX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 22, 2011 | K110381 | CELL-DYN EMERALD 22 SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 6, 2011 | K102568 | URIC ACID MODEL 3P39 | KNK | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 4, 2011 | K103403 | MULTICONSTITUENT CALIBRATOR | JIX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 19, 2010 | K093318 | ACCELERATOR APS | CEM | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 7, 2009 | K083809 | CREATININE | CGX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 4, 2009 | K081495 | CELL-DYN EMERALD SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| March 19, 2008 | K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | CIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 22, 2006 | K062855 | CALCIUM | CJY | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 10, 2006 | K061667 | CELL-DYN RUBY SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 5, 2006 | K060383 | GLUCOSE | CFR | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 4, 2006 | K060295 | CARBON DIOXIDE | KHS | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 25, 2005 | K051962 | ULTRA HDL | LBS | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 21, 2005 | K051215 | CELL-DYN SAPPHIRE SYSTEM | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 15, 2003 | K024067 | RHEUMATOID FACTOR (RF) | DHR | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 26, 2002 | K023807 | MODIFICATION TO ALKP | CJE | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 6, 2002 | K022180 | DIRECT BILIRUBIN | CIG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 4, 2002 | K020469 | CAL-CHEX CD PLUS | KRX | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| June 6, 2001 | K010953 | CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 18, 2000 | K000945 | PARA 12 PLUS RETICS | GLQ | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| May 19, 1999 | K991010 | ACP | CKB | Substantially Equivalent | Abbott Diagnostics Mfg., Inc. | accessdata.fda.gov |
| February 16, 1999 | K983070 | CK | CGS | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 29, 1999 | K983289 | APOLIPOPROTEIN A1 | DER | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 26, 1999 | K983281 | APOB | DFC | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983441 | C3 | CZW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983359 | IGA | CZP | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983356 | C4 | DBI | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983221 | IGG | DEW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983167 | TRF | DDG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983132 | IGM | DFT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 23, 1998 | K981791 | MG | JGJ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 28, 1998 | K983131 | AST | CIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 21, 1998 | K981682 | UPRO | JGQ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 28, 1998 | K981653 | AMY | JFJ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 28, 1998 | K981918 | UREA | CDQ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 22, 1998 | K981814 | ALBP | CJW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 9, 1998 | K981706 | AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 | JIX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 29, 1998 | K981652 | CHOL | CHH | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 29, 1998 | K981342 | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 16, 1998 | K981759 | PHOS | CEO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 12, 1998 | K981758 | ALBG | CIX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 1, 1998 | K980367 | AEROSET SYSTEM | CGZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 13, 2025 | 98031 | Class II | Ongoing | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during | accessdata.fda.gov |
| October 19, 2023 | 93355 | Class II | Ongoing | 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 processing using chemilum | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | accessdata.fda.gov |
| May 30, 2023 | 93483 | Class II | Ongoing | Alinity ci-series System Control Module, REF: 03R70-01 | There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintCo | accessdata.fda.gov |
| November 24, 2022 | 91303 | Class III | Ongoing | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels | Reaction vessels may contain a potential contaminant that could affect their optical performance. | accessdata.fda.gov |
| June 9, 2022 | 90499 | Class II | Ongoing | 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 | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. | accessdata.fda.gov |
| September 29, 2021 | 88880 | Class II | Ongoing | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 | Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate resu | accessdata.fda.gov |
| July 26, 2021 | 88502 | Class II | Ongoing | Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01 | Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sampl | accessdata.fda.gov |
| June 10, 2021 | 88123 | Class II | Ongoing | REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569 | There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results. | accessdata.fda.gov |
| April 2, 2020 | 85449 | Class II | Terminated | 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. The system allows con | In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results. | accessdata.fda.gov |
| May 22, 2019 | 85247 | Class II | Terminated | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay. | Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can resu | accessdata.fda.gov |
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Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.