Company:Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions
Date of Enforcement Report 5/30/12
Class ll:
PRODUCT
SafeTrace Tx, also rebranded as Horizon Blood Bank Haemonetics Software Solutions (formerly Wyndgate Technologies) Recall # B-1434-12
REASON
Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions), with a software glitch or defect that could result in an ABO incompatible blood transfusion, was distributed.
RECALLING FIRM/MANUFACTURER
Haemonetics Software Solutions, El Dorado Hills, CA, by letter on March 28, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
309 total units – 175 disks of Safe Trace Tx 3.6.0 and 3.4.1 and 134 disks of Horizon Blood Bank 3.6.0 and 3.4.1
DISTRIBUTION
Nationwide, Canada and Ethiopia
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