i-STAT CHEM8+ Cartridges and Controls (2018-06-05)

Starting date:

June 5, 2018

Posting date:

June 14, 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-67044

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  Reason
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  Affected products

Affected products

i-STAT CHEM8+ Cartridges and Controls

Reason

Abbott Point Of Care Inc. (APOC) has determined that when testing the listed CHEM8+ Cartridge lots with i-STAT TriControls fluids, elevated sodium results may be generated. The frequency of sodium results generated outside package insert limits as found on Value Assignment Sheets (VAS) or Electronic Value Assignment Sheets (EVAS) may be higher than usual.

Affected products