Urgent Product Correction: LeukoSure Enumeration Kit
Urgent Product Correction
LeukoSure Enumeration Kit
DATE CORRECTION INITIATED :
June 1, 2011
|Product Name||Part Number||Lot Number||Exp. Date|
Beckman Coulter, Inc.
Miami , Florida
The Beckman Coulter LeukoSure Enumeration Kits have an incorrect activity on their label due to the activity value for the raw material Ribonuclease A type III-A, utilized as a component of the LeukoSure Stain Reagent. The activity value for these lots is 3.25KU/ml, as compared to 4KU/ml as stated in the product labeling. Customers with test results that exceeded their laboratory established specifications are asked to reprocess the units of blood or test by another method permitted by their laboratory protocol.
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.