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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66244
Product Type Biologics
Status Ongoing
Recalling Firm Haemonetics Software Solutions
City El Dorado Hills
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Product was distributed to 34 consignees throughout the US and Puerto Rico, as well as to Saudi Arabia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Class II Blood Bank Software, with a defect or glitch, was distributed. 29 of 2.5.0, 30 of 2.5.0 (SR1), 35 of 2.6.0, 34 of 2.6 (SR1), 36 of 2.7.0 B-0008-14