BEUDAMED
    FDA Enforcement Class III Terminated

    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM

    Recall: Z-1330-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1330-2013
    Event ID
    64959
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 22, 2013
    Initiation Date
    April 15, 2013
    Classification Date
    May 16, 2013
    Termination Date
    August 1, 2013
    Address
    9500 Jeronimo Rd, Irvine, CA, 92618-2017, United States

    Description

    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM

    Reason

    The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.

    Code Info

    Lot Number 18972, Catalog Number 229 and 229PX.

    Distribution

    Worldwide Distribution - Distributed in San Juan Puerto Rico and the states of NM, NY, MN, OR and WI., and the countries of Australia, Brazil, France, Italy, Korea, and New Zealand.

    Quantity

    211 boxes and 5 MiniPaks