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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66136
Product Type Biologics
Status Ongoing
Recalling Firm Ortho Clinical Diagnostics Inc
City Raritan
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ortho Verseia Pipetter (VERSEIA) All VERSEIA Pipetters with software Versions 2.2, 2.3, 3.0 and 3.1; (Product Code: 5561701) There is no expiration date for these serialized products. Class III ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. 4 B-2518-13