Inc., Class Il Immucor

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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.