Company: Immucor, Inc.,
Date of Enforcement Report:8/23/2006
Class:ll
PRODUCT
Galileo Automated Blood Bank Analyzer (in-vitro diagnosis testing of human blood using a microplate platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red cell antibodies and compatibility testing), Recall #B-1645-6
REASON
Blood Bank Analyzer, with a software glitch, was distributed.
CODE
atalog Numbers: 0064997; 0064999
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by telephone beginning March 30, 2006 and by letter dated March 30, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
121 units
DISTRIBUTION
Nationwide, Canada and Japan
