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Abbott GmBH & Co. KG recalls Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canad

Recalled December 4, 2019 · FDA recall Z-0575-2020 · Abbott GmBH & Co. KG

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. · FDA Class II
Units
105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
Sold at
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, JAMAICA, LEBANON, MAURITIUS, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UAE, and UNITED KINGDOM

Description

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.

Product
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Manufacturer(s)
Abbott GmBH & Co. KG
Made in
Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Abbott GmBH & Co. KG recalls Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canad | RecallWatchUSA