CanadaThe i‑STAT EG7+ Cartridge (model/catalogue 03P76-25, lot N25209) by Abbott Point Of Care Inc. is affected. Cartridges from that lot may report higher than expected pCO2 and lower than expected pH due to a manufacturing issue, which can present a pattern suggestive of severe respiratory acidosis; use should be discontinued for pH and pCO2. Contact the manufacturer for additional information.
What's being recalled
Companies: Abbott Point Of Care Inc., 100 And 200 Abbott Park Rd., Abbott Park, Illinois, United States, 60064.
How to identify it
Affected products: i‑STAT EG7+ Cartridge; Lot or serial number: N25209; Model or catalogue number: 03P76-25
The hazard
Cartridges from the specific lots listed may report higher than expected pCO2 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 pCO2.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States