Data / Medical devices / United States / Abbott Point Of Care Inc.
Abbott Point Of Care Inc.: FDA-registered device maker in Princeton, NJ, United States, 25 510(k) clearances
Abbott Point Of Care Inc. is registered with the FDA (registration 2245578) in Princeton, NJ, United States. It lists 22 device types. The FDA files 25 510(k) clearances under its listings, the newest dated May 2, 2025. 42 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2245578
- Address
- 400 College Road East, Princeton, NJ, United States, 08540
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- Alinity c CRP Vario HS Control Kit (LN 07P5612), Alinity c Proteins Control Kit (LN 08P6712), Alinity i Anti-CCP Controls (LN 09P2710), Alinity i STAT CK-MB Controls (LN 04V3810), Alinity i STAT Myoglobin Controls (LN 04V3710), I-STAT Dispensing Tip, i-STAT 1 Analyzer (Models 300 & 300-G), i-STAT 1 analyzer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Lactic, Enzymatic Method | KHP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Activated Whole Blood Clotting Time | JBP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Biosensor, Immunoassay, Cpk Or Isoenzymes | MYT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Brain Trauma Assessment Test | QAT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Hematocrit Measuring | JPI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Calcium | JFP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Urea Nitrogen | CDS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Specification developer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Complaint file establishment | accessdata.fda.gov |
| Ph Rate Measurement, Carbon-Dioxide | JFL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | accessdata.fda.gov |
| Test, Natriuretic Peptide | NBC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Test, Time, Prothrombin | GJS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | CHL | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| January 3, 2025 | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | MMI | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| March 27, 2024 | K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | QAT | Substantially Equivalent | Abbott Point of Care | accessdata.fda.gov |
| October 27, 2023 | K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | JFP | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| October 27, 2023 | K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | CHL | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| October 27, 2023 | K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | JGS | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| September 15, 2023 | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | CHL | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| September 11, 2023 | K223755 | i-STAT G cartridge with the i-STAT 1 System | CGA | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| July 28, 2023 | K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | CGA | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| July 14, 2023 | K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | GJS | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 13, 2021 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | CGA | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| January 8, 2021 | K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | QAT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 9, 2020 | K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | CHL | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| February 28, 2020 | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JPI | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| February 14, 2020 | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JFP | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| February 7, 2020 | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JFL | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| February 7, 2020 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | JGS | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| February 7, 2020 | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | CGA | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| July 8, 2016 | K153357 | i-STAT Alinity System with i-STAT Sodium test | JGS | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| May 31, 2013 | K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | GGN | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| May 18, 2012 | K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | JJX | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| February 8, 2011 | K103195 | I-STAT 1 WIRELESS ANALYZER | CGA | Substantially Equivalent | Abbott Point of Care, Inc. | accessdata.fda.gov |
| June 2, 2008 | K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | Substantially Equivalent | Cliniqa Corporation | accessdata.fda.gov |
| October 5, 2000 | K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | CGA | Substantially Equivalent | I-Stat Corp. | accessdata.fda.gov |
| August 28, 1997 | K972868 | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL | JJY | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 1, 2026 | 98635 | Class II | Ongoing | i-STAT EG7+ cartridge; List Number: 03P76-25 | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the bl | accessdata.fda.gov |
| August 21, 2025 | 97443 | Class II | Ongoing | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300 | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. | accessdata.fda.gov |
| August 21, 2025 | 97442 | Class II | Ongoing | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2. | accessdata.fda.gov |
| December 22, 2020 | 87073 | Class II | Terminated | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25 | Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y. | accessdata.fda.gov |
| January 15, 2020 | 84728 | Class II | Terminated | i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (B | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, p | accessdata.fda.gov |
| January 14, 2020 | 84730 | Class II | Terminated | i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole b | Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020. | accessdata.fda.gov |
| October 16, 2019 | 84166 | Class II | Terminated | i-STAT cTnI cartridge | i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range. | accessdata.fda.gov |
| September 13, 2018 | 81151 | Class II | Terminated | Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25,(01)10054749000163(17)181028(10)L18059 | Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated | accessdata.fda.gov |
| September 12, 2017 | 79150 | Class II | Terminated | i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) | Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue. | accessdata.fda.gov |
| June 15, 2015 | 71665 | Class II | Terminated | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral an | Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR. | accessdata.fda.gov |
| January 1, 2014 | 67513 | Class II | Terminated | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances. | Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results. | accessdata.fda.gov |
| October 28, 2013 | 66757 | Class II | Terminated | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. | Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR. | accessdata.fda.gov |
| July 19, 2012 | 63309 | Class III | Terminated | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liqu | Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials. | accessdata.fda.gov |
| March 7, 2012 | 62410 | Class II | Terminated | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measuremen | Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation. | accessdata.fda.gov |
| March 1, 2012 | 62536 | Class II | Terminated | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. | The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. | accessdata.fda.gov |
| February 1, 2012 | 62533 | Class II | Terminated | i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I | The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. | accessdata.fda.gov |
| September 29, 2011 | 60048 | Not yet classified | Terminated | i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. | i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results. | accessdata.fda.gov |
| September 8, 2011 | 62319 | Class II | Terminated | iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are in | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | accessdata.fda.gov |
| February 15, 2011 | 58041 | Not yet classified | Terminated | i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base b | i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit. | accessdata.fda.gov |
| January 1, 2011 | 62371 | Class II | Terminated | I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arteri | i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer. | accessdata.fda.gov |
| December 17, 2010 | 57742 | Not yet classified | Terminated | Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to verify the integrity of n | Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set. | accessdata.fda.gov |
| December 3, 2010 | 57454 | Not yet classified | Terminated | Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical proce | Celite ACT cartridges have increased numbers of values outside the accepted allowable error. | accessdata.fda.gov |
| October 6, 2010 | 57005 | Not yet classified | Terminated | i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. | Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge. | accessdata.fda.gov |
| September 20, 2010 | 56832 | Not yet classified | Terminated | i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-ST | i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component. | accessdata.fda.gov |
| August 20, 2010 | 56560 | Not yet classified | Terminated | GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compat | Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer. | accessdata.fda.gov |
| August 3, 2010 | 56403 | Not yet classified | Terminated | i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in | Two cartridge lots were identified that may generate falsely elevated PCO2 results. | accessdata.fda.gov |
| August 3, 2010 | 56392 | Not yet classified | Terminated | i-STAT Level 2 Control Value Assignment Sheets Human Consumption | Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types. | accessdata.fda.gov |
| May 5, 2010 | 55895 | Not yet classified | Terminated | i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ | A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received. | accessdata.fda.gov |
| March 17, 2010 | 55178 | Not yet classified | Terminated | i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ. | The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks. | accessdata.fda.gov |
| February 5, 2010 | 54652 | Not yet classified | Terminated | i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the | Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle. | accessdata.fda.gov |
| November 6, 2009 | 53674 | Not yet classified | Terminated | Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and t | Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse. | accessdata.fda.gov |
| September 29, 2009 | 53483 | Not yet classified | Terminated | i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer | Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only. | accessdata.fda.gov |
| September 9, 2009 | 53335 | Not yet classified | Terminated | i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose | The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification. | accessdata.fda.gov |
| August 18, 2009 | 52754 | Not yet classified | Terminated | Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. | Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect. | accessdata.fda.gov |
| April 22, 2009 | 51872 | Not yet classified | Terminated | Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges. | It appears that the rechargeable battery pack is overheating with or without the presence of smoke. | accessdata.fda.gov |
| February 23, 2009 | 51211 | Not yet classified | Terminated | i-STAT EG7+ Cartridge; pH, PCO, PO, Na, K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific | Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals. | accessdata.fda.gov |
| January 1, 2008 | 56668 | Not yet classified | Terminated | i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540 | i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended. | accessdata.fda.gov |
| October 18, 2007 | 44972 | Not yet classified | Terminated | Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada. | Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | accessdata.fda.gov |
| December 12, 2006 | 36991 | Not yet classified | Terminated | i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 Product of Canada | Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges. | accessdata.fda.gov |
| September 25, 2006 | 56637 | Not yet classified | Terminated | i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, ven | Certain lots of G3+ cartridges may be difficult to fill. | accessdata.fda.gov |
| May 24, 2006 | 35513 | Not yet classified | Terminated | i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abb | Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained | accessdata.fda.gov |
| March 16, 2005 | 31502 | Not yet classified | Terminated | i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. | Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- All makers of Electrode, Ion Specific, Sodium
- All makers of Glucose Oxidase, Glucose
- All makers of Electrode, Ion-Specific, Chloride
- All makers of Electrode, Ion Specific, Potassium
Updated April 29, 2026. 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.