i-STAT G3+ Cartridge
The i-STAT G3+ cartridge measures blood pH and the partial pressures of oxygen and carbon dioxide with the i-STAT 1 analyzer. Trained medical professionals use it in point of care or…
The i-STAT G3+ cartridge measures blood pH and the partial pressures of oxygen and carbon dioxide with the i-STAT 1 analyzer. Trained medical professionals use it in point of care or clinical laboratories to assess respiratory, metabolic and acid-base disturbances.
The disposable cartridge contains sensors, a calibrant pouch, a sample entry well, fluid channels and a waste chamber. After the user adds whole blood and closes the cartridge, the analyzer moves fluid across the sensors and produces quantitative results for the tests simultaneously.
Listed Item
For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2
Sample Requirements
The cartridge accepts arterial, venous or capillary whole blood and requires approximately 95 microliters. Samples may be collected without anticoagulant or with balanced heparin or lithium heparin. Testing is for prescription in vitro diagnostic use.
1manufacturer
1catalogue number
4510(k) clearances naming this product code
31recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Abbott Point OF Care Inc., United States |
|---|---|
| FDA product code | CHL |
| Device type | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1120 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K223857 |
| Record published | 2023-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 03P78-26 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 80 |
| ABL80 SC80 | Radiometer Medical APS | 66 |
| ABL77 Sci | Radiometer Medical APS | 14 |
| Electrode for ABL analyzers | Radiometer Medical APS | 7 |
| Calibration Solution | Radiometer Medical APS | 7 |
| i-STAT | Abbott Point OF Care Inc. | 6 |
| ABL90 Sensor Cassette pack | Radiometer Medical APS | 6 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests) | Instrumentation Laboratory SPA | 5 |
| Nova | Nova Biomedical Corporation | 4 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests) | Instrumentation Laboratory SPA | 4 |
| Calibration Gas 2 | Radiometer Medical APS | 3 |
| Ready Sensor™ Lactate Biosensor | Siemens Healthcare Diagnostics Inc | 3 |
Showing 12 of 235. All products under Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K244014 | 2025-05-02 |
| K230285 | 2023-10-27 |
| K223857 | 2023-09-15 |
| K200492 | 2020-04-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Point OF Care Inc. | 510(k) number | 2026-04-01 | Class II | Process change control | 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 lowe | 40275 units (US only) |
Recalls
18 of these are Class II. Class II means a temporary or reversible health consequence. 5 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-04-01 | Class II | Process change control | 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 lowe | 30775 units (25625 US, 5150 OUS) | |
| 2026-04-01 | Class II | Process change control | 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 lowe | 369650 units (150875 US, 218775 OUS) | |
| 2025-08-21 | Class II | No Marketing Application | 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. | 547,250 units | |
| 2025-08-21 | Class II | No Marketing Application | 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. | 9,067,050 units | |
| 2025-08-21 | Class II | No Marketing Application | 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. | 6,115,950 units | |
| 2025-08-21 | Class II | No Marketing Application | 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. | 8,962,450 units | |
| 2020-12-22 | Class II | Under Investigation by firm | 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 f | 1,521,800 cartridges US and 2,641,053 cartridges OUS | 2023-09-01 |
| 2020-12-22 | Class II | Under Investigation by firm | 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 f | 2,820,000 cartridges US and 2,273,453 catridges OUS | 2023-09-01 |
| 2020-01-14 | Class II | No Marketing Application | 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 | 4,448,525 | 2021-04-12 |
| 2018-09-13 | Class II | Manufacturing material removal | 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 co | 17550 cartridges | 2019-04-04 |
| 2014-01-01 | Class II | Process control | 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. | 48, 450 US, 1400 OUS (49,850 catridges) | 2014-10-20 |
| 2011-09-08 | Class II | Device Design | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | 04J48-201-1069 units; 215001-217 units | 2013-01-28 |
| 2011-09-08 | Class II | Device Design | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | 6000-0000-650 units | 2013-01-28 |
| 2011-09-08 | Class II | Device Design | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | 06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 21 | 2013-01-28 |
| 2011-09-08 | Class II | Device Design | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; | 2013-01-28 |
| 2011-09-08 | Class II | Device Design | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | 04J48-01-56 units; 215000-695 units | 2013-01-28 |
| 2011-09-08 | Class II | Device Design | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. | 310003 -2203 units | 2013-01-28 |
| 2011-01-01 | Class II | Nonconforming Material/Component | 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. | 52,750 cartridges | 2013-05-22 |
| 2010-09-20 | Not classified | Other | 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. | 2202 | 2013-01-28 |
| 2010-09-20 | Not classified | Other | 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. | 650 | 2013-01-28 |
| 2010-09-20 | Not classified | Other | 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. | 04J48-20 – 1069; 215001 – 217. | 2013-01-28 |
| 2010-09-20 | Not classified | Other | 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. | 06F16-05: 45; 06F16-10: 22289; 310000: 4393; 310001: 1139; 3 | 2013-01-28 |
| 2010-08-03 | Not classified | Other | Two cartridge lots were identified that may generate falsely elevated PCO2 results. | 55350 total cartridges | 2011-12-05 |
| 2010-08-03 | Not classified | Other | Two cartridge lots were identified that may generate falsely elevated PCO2 results. | 55350 total cartridges | 2011-12-05 |
| 2009-02-23 | Not classified | Packaging process control | Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals. | 1048 boxes of 25 cartridges each. | 2009-07-29 |
| 2009-02-23 | Not classified | Packaging process control | Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals. | 1136 boxes of 25 cartridges each | 2009-07-29 |
| 2008-01-01 | Not classified | Other | 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. | 482,500 (total) | 2011-09-14 |
| 2008-01-01 | Not classified | Other | 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. | 482,500 (total number) | 2011-09-14 |
| 2008-01-01 | Not classified | Other | 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. | 482,500 (total) | 2011-09-14 |
| 2006-09-25 | Not classified | Other | Certain lots of G3+ cartridges may be difficult to fill. | 12,675 in US, 125 ROW | 2012-02-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.