BEUDAMED
    FDA Recall 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 · Initiated April 15, 2013

    Recall

    Recall Number
    Z-1330-2013
    Event Number
    64959
    Firm
    Bio-rad Laboratories, Inc.
    FEI Number
    2016706
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 15, 2013
    Posted
    May 16, 2013
    Terminated
    August 1, 2013
    Address
    9500 Jeronimo Rd, Irvine, CA, 92618-2017

    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.

    Action

    Bio-rad Laboratories initiated this recall on April 18, 2013, via telephone call and certified mailing to customers. The notification letter titled "Important Product Information Notice of Correction" was accompanied by a "Field Correction Notification Acknowledgement" form that notified customers of the product for recall (description and codes), issue (This product 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), Customers were instructed to immediately discontinue use this lot of Liquichek ToRCH Plus IgM Control. Discard all remaining inventory of this lot of Liquichek ToRCH Plus IgM Control that you have at your location in accordance with the requirements of your local waste management authorities. Handle this product with the same precautions used with patient specimens. In accordance with good laboratory practice, all human source material should be considered potentially infectious. Have the appropriate laboratory personnel complete the acknowledgment form and email or fax it to us. It is very important to us to know that you have received the information provided in this Notice. Contact information (1-800-2-BIORAD)

    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