BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0575-2020 · Initiated October 23, 2019

    Recall

    Recall Number
    Z-0575-2020
    Event Number
    84140
    Firm
    Abbott GmBH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
    FEI Number
    3002809144
    Product Code
    KHS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2019
    Terminated
    May 14, 2021

    Description

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

    Reason

    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.

    Action

    On 10/23/19, a Product Recall letter was issued to all worldwide Alinity c Carbon Dioxide Reagent customers who received the in-date lots. US customers were sent this information via FedEx priority overnight. Customers are asked to immediately discontinue use and destroy product from LN 07P7230 lot 54449UQ03. For LN 07P7220 lot 54454UQ03, the product may continue to be used but 2 levels of CO2 controls must be run every hour until the new material is received. If you or any of the health care providers you serve have any questions regarding this information, US Customers can contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the US , please contact your local area Customer Service.

    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, 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

    Quantity

    105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)