Abbott Laboratories
FDA Regulatory Profile
Summary
- Total Recalls
- 156 (41 Class I)
- 510(k) Clearances
- 888
- Inspections
- 153
- Compliance Actions
- 3
Known Names
st jude medical s c, abbott-labs, st jude medical cardiology division, st jude medical puerto rico, st jude medical, abbott-laboratories, st jude medical atrial fibrillation division, st jude medical neuromodulation division, abbott diagnostics division, abbott-diagnostics
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0961-2026 | Class II | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | November 13, 2025 |
| Z-0489-2026 | Class II | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 | September 18, 2025 |
| Z-1655-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Ver | March 18, 2025 |
| Z-1653-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Ver | March 18, 2025 |
| Z-1652-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Ver | March 18, 2025 |
| Z-1656-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Ver | March 18, 2025 |
| Z-1654-2025 | Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Ver | March 18, 2025 |
| Z-2681-2024 | Class II | Alinity hq Analyzer, REF: 09P68-01 | June 14, 2024 |
| Z-1476-2024 | Class II | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | February 21, 2024 |
| F-0328-2024 | Class II | Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - | October 31, 2023 |
| Z-0681-2024 | Class II | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated c | October 19, 2023 |
| Z-0680-2024 | Class II | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated i | October 19, 2023 |
| Z-0604-2024 | Class II | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sa | October 19, 2023 |
| Z-0682-2024 | Class II | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abb | October 19, 2023 |
| Z-0613-2024 | Class II | Alinity ci-series System Control Module, REF: 03R70-01 | May 30, 2023 |
| F-0698-2023 | Class II | Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per ca | March 28, 2023 |
| Z-0958-2023 | Class III | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels | November 24, 2022 |
| F-0161-2023 | Class II | Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 c | October 13, 2022 |
| F-0155-2023 | Class II | Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case | October 13, 2022 |
| F-0154-2023 | Class II | Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case | October 13, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243500 | ARCHITECT iGentamicin | July 9, 2025 |
| K243168 | Alinity i Rubella IgG | June 20, 2025 |
| K243283 | Alinity h-series System | February 20, 2025 |
| K233932 | Alinity i Toxo IgM | August 30, 2024 |
| K232669 | TBI | September 29, 2023 |
| K222850 | HAVAb IgG II | August 10, 2023 |
| K220031 | Alinity h-series System | August 4, 2023 |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | July 14, 2023 |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | June 5, 2023 |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alin | May 19, 2023 |
| K223602 | Traumatic brain injury (TBI) test | March 2, 2023 |
| K220949 | Architect CMV IgG | October 27, 2022 |
| K210596 | ARCHITECT Toxo IgG | May 19, 2022 |
| K213486 | GLP systems Track | March 10, 2022 |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | January 8, 2021 |
| K190294 | CELL-DYN Emerald 22 AL System | March 15, 2019 |
| K181748 | Magnesium | September 12, 2018 |
| K173294 | Magnesium | May 18, 2018 |
| K173122 | Abbott Architect Free T4 | October 27, 2017 |
| K170320 | Alinity c ICT Sample Diluent | October 24, 2017 |