Liquichek" ToRCH Plus IgM Control — Class III medical device recall Z-1330-2013

Terminated recall by Bio-rad Laboratories, Inc., reported 2013-05-22, distributed in MN, NM, NY, OR, PR, WI. The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from

Recall number	`Z-1330-2013`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Bio-rad Laboratories, Inc., Irvine, CA, United States
Recall initiated	2013-04-15
Classified	2013-05-16
Reported by FDA	2013-05-22
Terminated	2013-08-01
Distributed	MN, NM, NY, OR, PR, WI
Countries outside the US	AU, BR, FR, IT, KR, NZ
Lot numbers	`18972`
Model numbers	`229`, `229PX`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1330-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.