Recall Z-1330-2013 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Bio-rad Laboratories, Inc.
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 (C
| Date | May 16, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040822 | LIQUICHEK TORCH PLUS IGM CONTROL Bio-Rad Laboratories, Inc., May 19, 2004 |