i-STAT Alinity Instrument with Analyzer Software (2017-12-21)

Starting date:

December 21, 2017

Posting date:

January 29, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65794

• Reason
• Affected products

Affected products

i-STAT Alinity Instrument with Analyzer Software

Reason

This product action addresses two separate issues:

1. Abbott Point of Care (APOC) has determined that an increased frequency of quality check failure code 90-02 when testing i-STAT cartridges with the i-STAT Alinity software version Osi05 (JAMS 79A / CLEW D34).
2. Abbott Point of Care (APOC) has also determined that when testing with i-STAT cartridges that report pH, pCO2 and pO2, an i-STAT Alinity instrument with software version OSi05 (JAMS79A / CLEW D34) that is customized to correct for user entered patient temperature may report incorrect pH and/or pCO2 results.

Affected products