Reported May 22, 2013 · Terminated
Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed…
Bio-rad Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-rad Laboratories, Inc. · 9500 Jeronimo Rd · Irvine, CA · 92618-2017
Is this the product you have?
- 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
- Lot codes and dates
Lot Number 18972Catalog Number 229 and 229PX
- Amount recalled
- 211 boxes and 5 MiniPaks
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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