BEUDAMED
    FDA Enforcement Class II Ongoing

    cobas e801 Immunoassay Analyzer

    Recall: Z-1515-2022 · Reported August 17, 2022

    Enforcement

    Recall Number
    Z-1515-2022
    Event ID
    90657
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2022
    Initiation Date
    July 14, 2022
    Classification Date
    August 11, 2022
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    cobas e801 Immunoassay Analyzer

    Reason

    Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

    Code Info

    UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, DC & PR.

    Quantity

    965 units