Company: Medical Information Technology, Inc.
Date of Enforcement Report 10/5/11
Class ll:
PRODUCT
1) MEDITECH Blood Bank Software MAGIC 5.63 and 5.64. Recall # B-2169-11;
2) MEDITECH Blood Bank Software Client Server 5.65, 6.05 and 6.06. Recall # B-2170-11
REASON
Software, with a glitch or defect which could lead to an incompatible unit being transfused, was distributed.
RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA, by e-mail task updates on July 15, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1) 354; 2) 274
DISTRIBUTION
Nationwide, Canada, UK, South Africa
