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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Corporate Office

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