i-STAT EG7+ Cartridge Recall for pH Errors
Summary
Health Canada has issued a Type II recall for Abbott Point of Care Inc.'s i-STAT EG7+ Cartridge due to a manufacturing defect causing inaccurate pH and pCO2 readings. Affected lots (N25209, Model 03P76-25) may report higher than expected pCO2 and lower than expected pH results, potentially leading to inappropriate clinical interventions. Healthcare providers should immediately discontinue use of these cartridges for pH and pCO2 testing and contact the manufacturer for additional information.
What changed
Health Canada has issued a Type II medical device recall for Abbott Point of Care Inc.'s i-STAT EG7+ Cartridge due to a manufacturing defect affecting specific lot N25209 (Model 03P76-25). The cartridges may report higher than expected pCO2 and lower than expected pH results, potentially presenting a pattern suggestive of severe respiratory acidosis.\n\nHealthcare providers using these cartridges should immediately discontinue their use for pH and pCO2 testing and contact Abbott Point of Care Inc. for replacement products. Failure to identify inaccurate results could lead to unnecessary or inappropriate clinical interventions based on misleading diagnostic data. This recall requires urgent attention from all healthcare facilities performing point-of-care blood gas analysis.
What to do next
- Discontinue use of affected i-STAT EG7+ Cartridges for pH and pCO2 testing
- Contact Abbott Point of Care Inc. for replacement products
- Report any health or safety concerns to Health Canada
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
i‑STAT EG7+ Cartridge
Brand(s)
Last updated
2026-04-15
Summary
Product i‑STAT EG7+ Cartridge Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| i‑STAT EG7+ Cartridge | N25209 | 03P76-25 |
Issue
Cartridges from the specific lots listed may report higher than expected pCO 2 and lower than expected pH results due to a manufacturing issue which may present a pattern suggestive of severe respiratory acidosis. If such results are acted upon without consideration of the patient's overall clinical presentation, this could lead to unnecessary or inappropriate clinical interventions. Use of the cartridges should be discontinued for pH and pCO 2.
Additional information
Details
Original published date:
2026-04-15
Alert / recall type Health product recall Category Health products - Medical devices - Chemistry Companies
| Abbott Point Of Care Inc. |
| 100 And 200 Abbott Park Rd., Abbott Park, Illinois, United States, 60064 |
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-04-02
Identification number RA-81897
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