FDA Medical Device · Z-0575-2020

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

Class II · Terminated

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.

Affected lots / codes — check yours against thisREF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03

Recalling firm: Abbott GmBH & Co. KG, Wiesbaden,
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
Distribution: Worldwide and US Nationwide in the states of: AL, AR, CA, CO, FL, GA, ID, IL, LA, MA, MI, MN, MO, NC, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico Foreign: AUSTRALIA, BANGLADESH, BELGIUM, BOTSWANA, BRAZIL, CANADA, COLOMBIA, DENMARK, FRANCE, GREECE, Hong Kong, INDIA, ITALY, J…
Recall initiated: October 23, 2019
Classified: November 25, 2019
Terminated: May 14, 2021
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0575-2020%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

See every recall for this brand: Is Abbott GmBH & Co. KG recalled? →

Check this brand across all 8 databases →