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U.S. Department of Health and Human Services

Class 3 Device Recall Liquichek ToRCH Plus IgM Control

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  Class 3 Device Recall Liquichek ToRCH Plus IgM Control see related information
Date Initiated by Firm April 15, 2013
Date Posted May 16, 2013
Recall Status1 Terminated 3 on August 01, 2013
Recall Number Z-1330-2013
Recall Event ID 64959
510(K)Number K040822  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product 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

Code Information Lot Number 18972, Catalog Number 229 and 229PX.
Recalling Firm/
Manufacturer		 Bio-rad Laboratories, Inc.
9500 Jeronimo Rd
Irvine CA 92618-2017
For Additional Information Contact
949-598-1200
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Material/Component Contamination
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)
Quantity in Commerce 211 boxes and 5 MiniPaks
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = BIO-RAD LABORATORIES, INC.
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