Answers
10/26/1993

T93-47                                             Monica Revelle
Oct. 26, 1993                                      (301) 443-4177

<TITLE>IDAHO AMERICAN RED CROSS RECALLS BLOOD PRODUCTS</TITLE>
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         IDAHO AMERICAN RED CROSS RECALLS BLOOD PRODUCTS

     FDA has been receiving inquiries about a recall by the
American Red Cross (ARC) in Boise, Idaho, of a substantial number
of blood products.  The recall of 2,291 units was initiated because
it was determined that blood was collected from donors who had
previously tested repeatedly reactive in HIV screening tests in
1985 and 1986.  The following can be used to answer questions.
     The recalled blood products, which tested negative for anti-
HIV, were manufactured from blood collected between March 1985 and
December 1991, and included whole blood, red blood cells,
platelets, plasma and cryoprecipitate blood component used to aid
clotting.
     Audits of the testing procedures at ARC in Boise revealed that
of the 2,291 units, 1,169 units were collected from donors whose
original tests results were later determined to be false positives. 
The remaining 1,122 units were collected from donors who were
ineligible to donate due to previous test results.
     The audits also indicated that a data entry error resulted in
these ineligible donors not being classified as "deferred donors"
in the donor deferral registry.  Deferred donors are placed in the
deferral registry to exclude them from giving blood because of a
questionable health history or disqualifying blood tests.  
                             -MORE-

                                        Page 2, T93-47, Idaho ARC
     ARC in Idaho notified, by telephone and follow-up letters, the
21 blood centers, 47 hospitals and 7 manufacturers in 20 states who
received the blood products.  ARC in Idaho has determined the final
disposition for all the transfusable products. In addition, ARC in
Idaho is continuing to audit those products, such as recovered
plasma and expired red blood cells, used in further manufacturing
of blood products.
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