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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Market Withdrawal of Chiron RIBA HCV 3.0 SIA

DATE NOTIFICATON INITIATED:

February 26, 2010

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Chiron RIBA HCV 3.0 SIA 

Product Code:  930600

Lot Numbers

Expiration Date

YA1209

June 22, 2009

YA1691

August 31, 2009

YA1758

September 22, 2009

YA1804

September 29, 2009

98290

May 17, 2010

98743

May 31, 2010

MANUFACTURER:

Novartis Vaccines and Diagnostics
Emeryville, CA

REASON:

Novartis Vaccines and Diagnostics, Inc. (Novartis Diagnostics) received complaints from customers reporting false positive assay results when using the Chiron RIBA HCV 3.0 SIA (Strip Immunoblot Assay).


Novartis Diagnostics initiated an investigation including a review of all batch records for the lots listed above and determined that all lots were manufactured according to established procedures and met all performance specifications.  In addition, the kits lots were retested as part of this investigation and confirmed all lot-release specifications continue to be met.  However, as part of the investigational testing performed to date, Novartis Diagnostics reproduced discordant results with specimens returned from customers on certain lots of Chiron RIBA HCV 3.0 SIA.  The etiology of these discordant results is undetermined, and testing evidence supports that an increase in false positive results is possible with the lots listed above.  Internal testing of known positive specimens on retained lots yielded accurate results; therefore, Novartis has no evidence that true positive specimen results are impacted.  Customers have been asked to contact the manufacturer to arrange for product return.
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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA.  Its accuracy and comprehensiveness cannot be guaranteed.