Abbott Laboratories
Abbott Laboratories holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2026, with 58 FDA device recalls on record.
Top product codes for Abbott Laboratories
FDA recalls by Abbott Laboratories
10 most recent of 58- Z-0961-2026 — Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
- Z-0489-2026 — 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 Analyzer Component: No
- Z-1654-2025 — 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
- Z-1655-2025 — 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
- Z-1652-2025 — 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
- Z-1656-2025 — 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
- Z-1653-2025 — 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
- Z-2681-2024 — Alinity hq Analyzer, REF: 09P68-01
- Z-1476-2024 — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
- Z-0682-2024 — 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 photometry and potentiometric technology.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott Laboratories
1–100 of 883- K252424 — Anti-HCV Next
- K243500 — ARCHITECT iGentamicin
- K243168 — Alinity i Rubella IgG
- K243283 — Alinity h-series System
- K233932 — Alinity i Toxo IgM
- K232669 — TBI
- K222850 — HAVAb IgG II
- K220031 — Alinity h-series System
- K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System
- K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track
- K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
- K223602 — Traumatic brain injury (TBI) test
- K220949 — Architect CMV IgG
- K210596 — ARCHITECT Toxo IgG
- K213486 — GLP systems Track
- K201778 — i-STAT TBI Plasma cartridge with the i-STAT Alinity System
- K190294 — CELL-DYN Emerald 22 AL System
- K181748 — Magnesium
- K173294 — Magnesium
- K173122 — Abbott Architect Free T4
- K170320 — Alinity c ICT Sample Diluent
- K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i System
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
- K163342 — i-STAT Hematocrit test with i-STAT Alinity System
- K170160 — Abbott ARCHITECT Free T3
- K153375 — ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
- K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
- K152155 — ARCHITECT 2nd Generation Testosterone
- K152442 — Freestyle Freedom Blood Glucose Monitoring Sytem
- K151566 — Abbott ARCHITECT Total T4 Calibrators
- K150332 — FreeStyle Lite Blood Glucose Monitoring System
- K150531 — FreeStyle Freedom Lite Blood Glucose Monitoring System
- K140654 — Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
- K150510 — Total Bilirubin
- K130255 — HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
- K123089 — FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
- K121985 — ARCHITECT TOTAL BILIRUBIN
- K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
- K121003 — ABBOTT PLEX-ID FLU ASSAY
- K123379 — ABBOTT ARCHITECT FREE T4
- K120009 — TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
- K113704 — ARCHITECT HAVAB-G
- K121314 — ARCHITECT B12
- K113719 — SAFETY SCREW CONNECTOR
- K111874 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
- K110381 — CELL-DYN EMERALD 22 SYSTEM
- K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS
- K110579 — ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
- K111023 — ABBOTT ARCHITECT LH CALIBRATORS
- K102568 — URIC ACID MODEL 3P39
- K110909 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
- K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
- K103403 — MULTICONSTITUENT CALIBRATOR
- K092740 — ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74
- K093318 — ACCELERATOR APS
- K083809 — CREATININE
- K081495 — CELL-DYN EMERALD SYSTEM
- K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
- K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
- K081549 — RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
- K071525 — ACTIVATED ASPARTATE AMINOTRANSFERASE
- K072824 — FOX SV PTA CATHETER
- K063329 — ABBOTT ARCHITECT HAVAB-M
- K062855 — CALCIUM
- K062843 — FOX SV PTA CATHETER
- K061667 — CELL-DYN RUBY SYSTEM
- K060875 — ABBOTT AXSYM TROPONIN-I ADV
- K061249 — AXSYM DIGOXIN III
- K060383 — GLUCOSE
- K060295 — CARBON DIOXIDE
- K060574 — TOTAL BILIRUBIN
- K053330 — ARCHITECT B12 CALIBRATORS
- K051962 — ULTRA HDL
- K051327 — ABBOTT AXSYM B12
- K051215 — CELL-DYN SAPPHIRE SYSTEM
- K051125 — IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
- K050534 — XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K050103 — XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K041962 — XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
- K041811 — ABBOTT AXSYM TROPONIN-I ADV
- K041687 — ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
- K041550 — HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K040814 — MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
- K040667 — XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
- K040628 — PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
- K033909 — WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
- K040114 — ABBOTT DATA PORT PC, MODEL 12181
- K033845 — PRECISION XCEED DIABETES MONITORING SYSTEM
- K033537 — SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
- K033576 — LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
- K032458 — ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR
- K030899 — C-REACTIVE PROTEIN (CRP)
- K030513 — CELL-DYN 1800 SYSTEM
- K031185 — ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
- K023256 — PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
- K030002 — LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
- K024067 — RHEUMATOID FACTOR (RF)
- K024126 — CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
- K024239 — CHEMO DISPENSING PIN, MODEL 12495
- K024084 — ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
Data sourced from openFDA. This site is unofficial and independent of the FDA.