Alinity c Carbon Dioxide Reagent Kit (2019-11-28)

Starting date:

October 28, 2019

Posting date:

November 8, 2019

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-71563

Last updated: 2019-11-08

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  Reason
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  Affected products

Affected Products

Alinity c Carbon Dioxide Reagent Kit

Reason

Abbott internal studies have determined that atmospheric carbon dioxide (CO2) can be absorbed into the Alinity c carbon dioxide reagent, resulting in the potential for incorrect results.  This testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.

Affected products