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|
Novartis Vaccines and Diagnostics
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.
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.