I-stat 1 Analyzer system - G3+ Cartridge (2014-01-30)

Starting date:

January 30, 2014

Posting date:

March 20, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-38453

• Reason
• Affected products

Recalled Products

I-stat 1 Analyzer system - G3+ Cartridge 

Reason

Abbott point of care Inc. (APOC) has determined that I-stat G3+ cartridges from cartridge lot number N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results. Abbott point of care has determined that some individual patient results generated with this cartridge lot have the potential to exhibit incorrectly elevated pco2 and depressed pH results. Internal studies have demonstrated that PCO2 results can be elevated by 10 to 25 mm HG, pH results can be depressed by 0.10 to 0.15. All other G3+ cartridge lots are unaffected by this issue.

Affected products