FDAClass IIIMay 22, 2013

Liquichek" ToRCH Plus IgM Control - Positive Liquichek recall

Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor…

Why was Liquichek" ToRCH Plus IgM Control - Positive Liquichek 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 18972, Catalog Number 229 and 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…
Recalling firm
Bio-rad Laboratories, Inc.
Quantity
211 boxes and 5 MiniPaks
Distribution
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.
Recall date
May 22, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls