BEUDAMED
    FDA Recall Terminated

    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

    Recall: Z-2498-2021 · Initiated August 4, 2021

    Recall

    Recall Number
    Z-2498-2021
    Event Number
    88600
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    QLT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 4, 2021
    Terminated
    February 23, 2024
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

    Reason

    Customers have reported an increased number of false positive SARS-CoV-2 results.

    Action

    On August 4, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were instructed to take the following actions: - Immediately discontinue the use of the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat system, lot number 10119Z. - For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat system, follow your laboratory s standard operating procedures to investigate the potential for false positive results. Please consult with the physician or clinicians at your facility to determine specific clinical implications for your patients. - Repeat testing can be performed using other cobas SARS-CoV-2 & Influenza A/B lot numbers. - Complete all sections of the enclosed faxback form and fax it to 1-888-312-5960 or email it to [email protected]. - Discard lot number 10119Z according to your local waste management ordinance. - File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-800-5973 if you have questions about this recall.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.

    Quantity

    211 kits (US); 3073 kits (OUS)