The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Devices)·Z-1330-2013·Announced 2013-05-22

Bio-Rad Recalls Liquichek ToRCH Plus IgM Control Due to HCV RNA

Bio-Rad is recalling Liquichek ToRCH Plus IgM Control - Positive because it contains detectable levels of HCV RNA originating from the manufacturing process.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The presence of HCV RNA in a quality control serum represents a contamination issue, but the product is not intended for direct patient use or blood donor screening, limiting the immediate risk.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling the Liquichek ToRCH Plus IgM Control - Positive product. This product is an unassayed quality control serum intended to monitor the precision of IgM laboratory testing procedures for specific analytes, including Cytomegalovirus, Herpes Simplex Virus, Rubella Virus, and Toxoplasma gondii. The product is not intended for use in blood donor screening assays.

The recall is being issued because the product contains detectable levels of Hepatitis C Virus (HCV) RNA. According to the source text, this HCV RNA originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.

The affected units include 211 boxes and 5 MiniPaks of Lot Number 18972, Catalog Number 229 and 229PX. The product was distributed worldwide, specifically in San Juan, Puerto Rico, and the states of New Mexico, New York, Minnesota, Oregon, and Wisconsin, as well as in Australia, Brazil, France, Italy, Korea, and New Zealand. Users should stop using the affected product and contact Bio-Rad Laboratories for further instructions.

The recalled product

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…
Manufacturer
Bio-rad Laboratories, Inc.
Category
Medical Device — Laboratory Reagent
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number 18972
  • Catalog Number 229 and 229PX.

Distribution

Distributed in 6 states:

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