CLASS III Device recall · Reported 22 May 2013 · FDA Enforcement Report

Liquichek" ToRCH Plus IgM Control recalled by Bio-rad Laboratories

Bio-rad Laboratories is recalling Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended, distributed in Minnesota, New Mexico, New York, Oregon, Puerto Rico, Wisconsin. The recall was initiated on 15 Apr 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Number 18972, Catalog Number 229 and 229PX.

Quantity recalled211 boxes and 5 MiniPaks

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1330-2013
FDA event ID: 64959
Recalling firm: Bio-rad Laboratories, Irvine, CA
Classification: Class III
Status: Terminated
Recall initiated: 15 Apr 2013
FDA classified: 16 May 2013
Reported: 22 May 2013
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

15 Apr 2013	Recall initiated by company
16 May 2013	Classified by FDA	+31 days
22 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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.

Minnesota New Mexico New York Oregon Puerto Rico Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number 18972, Catalog Number 229 and 229PX.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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