Abbott GmBH & Co. KG recalls Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott b
Recalled Product
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Hazard / Issue
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. Abbott was made aware of this issue from customer complaints. Internal 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.
Issued by
FDA
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