Company: Haemonetics Software Solutions
Date of Enforcement Report:12/11/2013
Class lI:
PRODUCT
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
REASON
Blood Bank Software, with a defect or glitch, was distributed.
RECALLING FIRM/MANUFACTURER
Haemonetics Software Solutions, El Dorado Hills, CA on 8/22/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
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
DISTRIBUTION
Nationwide and Internationally
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