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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description Ortho Verseia Pipetter (VERSEIA)
Recall Number B-2518-13
Classification Class III
Code Info 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.
Product Distributed Qty 4
Reason For Recall ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results.

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 Telephone
Distribution Pattern Nationwide