i-STAT
EG7+ Cartridge
1manufacturer
6catalogue numbers in this listing
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) | K940918 |
| Record published | 2016-09-09 |
| Record revised | 2026-02-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
| Packaging | Case of 25 |
| Distribution end date | 2023-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03P78-25 | In distribution | |
| 03P76-25 | In distribution | |
| 03P88-25 | In distribution | |
| 03P79-25 | In distribution | |
| 03P77-25 | In distribution | |
| 03P78-50 | Withdrawn |
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 |
| 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 |
| Calibration gas 1 | Radiometer Medical APS | 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
19 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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 | 369650 units (150875 US, 218775 OUS) | |
| 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 | 30775 units (25625 US, 5150 OUS) | |
| Abbott Point OF Care Inc. | 510(k) number | 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 | |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 2010-08-03 | Not classified | Other | Two cartridge lots were identified that may generate falsely elevated PCO2 results. | 55350 total cartridges | 2011-12-05 |
| Abbott Point OF Care Inc. | 510(k) number | 2010-08-03 | Not classified | Other | Two cartridge lots were identified that may generate falsely elevated PCO2 results. | 55350 total cartridges | 2011-12-05 |
| Abbott Point OF Care Inc. | 510(k) number | 2010-02-05 | Not classified | Other | 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. | 40,446 total cartridges, all varieties | 2012-07-25 |
| Abbott Point OF Care Inc. | 510(k) number | 2010-02-05 | Not classified | Other | 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. | 40,446 total cartridges, all varieties | 2012-07-25 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. 4 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 | 40275 units (US only) | |
| 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 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 | |
| 2020-01-14 | 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 |
| 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 |
| 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 |
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.