Vaccines, Blood & Biologics

Urgent Biological Product Notification Seraclone Anti-S

DATE NOTIFICATION INITIATED: April 9, 2013

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Seraclone Anti-S, Catalog Number 808052100
Lot #8136070-01, Expiration Date August 29, 2013
Lot # 8203120-01, Expiration Date January 9, 2014

MANUFACTURER:

Bio-Rad Laboratories, Inc.
Redmond, Washington

REASON:

Bio-Rad Laboratories is notifying customers that ongoing stability testing of Seraclone Anti-S product has shown a decreased reactivity in lot numbers 8136070-01 and 8203120-01.

This decrease in reactivity has the potential to result in weaker than expected reactions. Current customer reports have indicated that this is seen in quality control testing. No reports of erroneous testing in patients have been received. No retesting of patients is required if the recommended quality control testing was performed and met expected values.

Customers are requested to discontinue use of these lots of Seraclone Anti-S.


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.

Page Last Updated: 08/19/2014
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