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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Product Correction: LeukoSure Enumeration Kit

Urgent Product Correction

LeukoSure Enumeration Kit

DATE CORRECTION INITIATED :

June 1, 2011

PRODUCT:

Product Name

Part Number

Lot Number

Exp. Date

LeukoSure
Enumeration Kit

 175621

5621012K
5621013K
5621014K

02/15/2011
05/17/2011
07/26/2011

MANUFACTURER:

Beckman Coulter, Inc.
Miami , Florida

REASON:

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.

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