Company: Immucor, Inc.,
Date of Enforcement Report:8/23/2006
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
Blood Bank Analyzer, with a software glitch, was distributed.
atalog Numbers: 0064997; 0064999
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
Nationwide, Canada and Japan