Correction/removal reporting number = 3002809144-10/24/19-009-r.The investigation into this matter found that the amount of co2 absorbed was higher with increased reagent carousel rotation and when the volume of the reagent in the cartridge is reduced.This phenomenon could be detected as a shift in qc and also incorrect patient results.A product recall letter was sent to all customers who have received shipments of the impacted lots of the alinity c carbon dioxide reagent kit.The letter instructs the following: immediately discontinue use of the alinity c carbon dioxide 15000t kit and destroy any remaining inventory as existing modes of control are not effective for the large cartridge.Run two levels of co2 controls every hour with the use of the current alinity c carbon dioxide 3000t kit, instead of every 24 hours, and perform assay calibration as needed to minimize the potential to generate incorrect results.All current inventory of alinity c carbon dioxide (ln 07p7220), will be reworked to include a kit stuffer instructing customers to run qc every hour.In future lots of the alinity c carbon dioxide 3000t kit, the reagent cartridge fill volume will be increased from 12.7 ml to 20.7 ml, which has been confirmed to minimize co2 absorption.
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The customer reported the limits for carbon dioxide (co2) are frequently not within the expected range for the biorad quality control (qc) on the alinity analyzer.As a result, the customer tested technopath controls every 4 hours on the 3 levels, which confirmed the results that were generated by the biorad qc materials; the results were fluctuating too low and too high.There was no reported impact to patient management.
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