Abbott Point Of Care Inc.
FDA Regulatory Profile
Abbott Point Of Care Inc. appears in FDA public data with 31 recalls, 22 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2001-2026, Class II) was initiated on April 1, 2026. Its most recent 510(k) clearance was granted on June 26, 2026.
Summary
- Total Recalls
- 31
- 510(k) Clearances
- 22
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2001-2026 | Class II | i-STAT G3+ cartridge; List Number: 03P78-26; | April 1, 2026 |
| Z-1999-2026 | Class II | i-STAT EG7+ cartridge; List Number: 03P76-25; | April 1, 2026 |
| Z-2000-2026 | Class II | i-STAT EG6+ cartridge; List Number: 03P77-25; | April 1, 2026 |
| Z-2584-2025 | Class II | i-STAT EG7+ cartridge. List Number: 03P76-25. | August 21, 2025 |
| Z-2582-2025 | Class II | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | August 21, 2025 |
| Z-2585-2025 | Class II | i-STAT EG6+ cartridge. List Number: 03P77-25. | August 21, 2025 |
| Z-2583-2025 | Class II | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K23027 | August 21, 2025 |
| Z-0880-2021 | Class II | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ioni | December 22, 2020 |
| Z-0881-2021 | Class II | Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, i | December 22, 2020 |
| Z-1262-2020 | Class II | i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-S | January 15, 2020 |
| Z-1263-2020 | Class II | i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT | January 15, 2020 |
| Z-1265-2020 | Class II | i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT | January 14, 2020 |
| Z-0761-2020 | Class II | i-STAT cTnI cartridge | October 16, 2019 |
| Z-0615-2019 | Class II | Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arteri | September 13, 2018 |
| Z-0926-2018 | Class II | i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46- | September 12, 2017 |
| Z-2361-2015 | Class II | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one | June 15, 2015 |
| Z-1306-2014 | Class II | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and trea | January 1, 2014 |
| Z-0451-2014 | Class II | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a pr | October 28, 2013 |
| Z-0192-2013 | Class III | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 0710 | July 19, 2012 |
| Z-2237-2012 | Class II | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for | March 7, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | June 26, 2026 |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | June 11, 2026 |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | May 2, 2025 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | January 3, 2025 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | March 27, 2024 |
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | October 27, 2023 |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | October 27, 2023 |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | October 27, 2023 |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | September 15, 2023 |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | September 11, 2023 |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | July 28, 2023 |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | August 13, 2021 |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | April 9, 2020 |
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 28, 2020 |
| K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 14, 2020 |
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 7, 2020 |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 7, 2020 |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | February 7, 2020 |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | April 10, 2017 |
| K153357 | i-STAT Alinity System with i-STAT Sodium test | July 8, 2016 |