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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Panoscreen lll

DATE RECALL INITIATED:
July 16, 2010

PRODUCT / LOT NUMBER Expiration date:
Immucor Panoscreen lll
Lot Number: 24223
Expiration Date: August 20, 2010

MANUFACTURER:
Immucor, Inc.
Norcross, Georgia

REASON:
It has come to Immucor’s attention that Panoscreen III, lot 24223 does not include an S positive donor cell. This carries an increased risk of clinically significant alloantibody to go undetected and could potentially lead to a transfusion reaction or Hemolytic Disease of the Newborn. Immucor is notifying customers so they may evaluate the impact on results generated with this product lot. Immucor recommends that customers repeat testing, with at least one S positive cell, any samples that generated negative antibody screening results with this lot. Immucor also requests customers to discontinue use of this lot and to contact Customer Service to arrange for replacements.