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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description 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
Recall Number B-0008-14
Classification Class II
Code Info Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0
Product Distributed Qty 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
Reason For Recall Blood Bank Software, with a defect or glitch, was distributed.

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 Letter
Distribution Pattern Product was distributed to 34 consignees throughout the US and Puerto Rico, as well as to Saudi Arabia.