BEUDAMED
    FDA Enforcement Class II Terminated

    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    Recall: Z-2487-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2487-2021
    Event ID
    88578
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 29, 2021
    Initiation Date
    August 20, 2021
    Classification Date
    September 17, 2021
    Termination Date
    January 12, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    Reason

    The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.

    Code Info

    Catalog # HE0063S Lot #'s: HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1 and HE0063-100-1.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.

    Quantity

    127