UNCLASSIFIED
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21
ORIGIN HEW-06
INFO OCT-01 ISO-00 OES-05 EUR-12 AF-06 MED-03 /033 R
DRAFTED BY DHEW/FDA/JRWEINROTH; M.D.
APPROVED BY OES/SCI/BMP:MBEAUBIEN
DHEW/OIH/MACODDING
EUR/WE:KHSHIRLEY (INFO)
AF/S:RJDOLS (INFO)
--------------------- 037881
R 241527Z APR 75
FM SECSTATE WASHDC
TO AMEMBASSY BRUSSELS
AMEMBASSY PRETORIA
UNCLAS STATE 094433
E.O. 11652: N/A
TAGS: OGEN, ETRD, TBIO, BE, SF.
SUBJECT: FDA ADVISORY-SUBPOTENT DIAGNOSTIC PRODUCT
1. FDA ADVISES THAT THE HEPATITIS B SURFACE ANTIGEN (HUMAN)
(SUBTYPE A Y W) COATED HUMAN RED BLOOD CELLS LABELED "FOR USE
IN PHA TESTS, CAUTION: MAY TRANSMIT HEPATITIS." MANUFACTURED BY
ELECTRO-NUCLEONICS LABORATORIES, INC., BETHESDA, MARYLAND 20014
IN THREE ML. AND 25 ML. VIALS IS SUBPOTENT. THE LOT NO. OF THE
A Y W CELLS INVOLVED IS 002. THIS LOT NUMBER IS STAMPED ON VIALS
WITH LIST NO. 2052 (3 ML.) AND LIST NO. 2053 (25 ML.) WHICH WERE
PACKAGED IN VIRGO REAGENTS TEST KIT NO. 2000, LOT NO. 1073.
2. VIRGO REAGENTS TEST KIT NO. 2000, HEPATITIS B SURFACE ANTIGEN
(HUMAN) COATED HUMAN RED BLOOD CELLS, IS USED IN A PASSIVE
HEMAGGLUTINATION TEST FOR THE DETECTION OF ANTIBODY TO THE
HEPATITIS B SURFACE ANTIGEN. THE "DIRECTIONS FOR USE" FOR THIS TEST
KIT ARE GIVEN ON THE PRODUCT INSERT. IN GENERAL, THE TEST IS POSI-
TIVE WHEN THE HEPATITIS ANTIGEN (LIST NO. 2052 OR NO. 2053)
COMBINES WIT A PATIENT'S BLOOD SAMPLE (ANTIBODY) TO FORM AN AGGUL-
TINATION. AT THE SAME TIME, A CONTROL IS RUN USING A STANDARDIZED
ANTIBODY (LIST NO. 6048) USING VARIOUS DILUTIONS. WHEN A POSITIVE
TEST RESULT IS OBTAINED FROM AN ANTIBODY DILUTION GREATER THAN
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1 TO 28, THE TEST IS DEEMED FAULTY. IT WOULD INDICATE THAT THE
STABILITY OF THE HEPATITIS ANTIGEN HAS DETERIORATED. THIS IS THE
CASE WITH LOT NO. 002 OF HEPATITIS B SURFACE ANTIGEN (HUMAN)
7?5603 A Y W) COATED HUMAN RED BLOOD CELLS.
3. POSTS ARE REQUESTED TO DETERMINE IF THE FOREIGN CONSIGNEES
HAVE RECEIVED ADVISORY FROM FIRM INDICATING POSSIBLE PROBLEM
WITH DIAGNOSTIC PRODUCT.
4. FOREIGN CONSIGNEES AS FOLLOWS:
UNIVERSITY CATHOLIQUE CLINIQUES UNIVERSITAIRES SAINT-PIERRE,
BRUSSELSESTRAAT 69, B-3000 LEUVEN, BELGIUM
T AND C SCIENTIFIC SUPPLIES, P.O. BOX 1366 JOHANNESBURG, SOUTH
AFRICA END
KISSINGER
UNCLASSIFIED
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