FDAOctober 23, 2019device

Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

abbott gmbh co kgabbottabbott gmbh

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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