Recall Z-1330-2013— Bio-rad Laboratories, Inc.

Name: FDA recall Z-1330-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-15

Class III · Terminated

Class III FDA medical device recall by Bio-rad Laboratories, Inc., initiated 2013-04-15, terminated 2013-08-01. It names one FDA 510(k) clearance: K040822. 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. 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..

Recalling firm: Bio-rad Laboratories, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-04-15
Terminated: 2013-08-01
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K040822 — LIQUICHEK TORCH PLUS IGM CONTROLBio-Rad Laboratories, Inc.·cleared 2004-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.