Health product recall

i‑STAT EG7+ Cartridge

Last updated

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 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.

Additional information

Details
Original published date:
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
Identification number
RA-81897

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