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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

Product Description Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002
Recall Number B-2265-13
Classification Class II
Code Info Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002
Product Distributed Qty 1
Reason For Recall Laboratory software, with a defect or glitch, was distributed.

Event Detail

Event Id 65336
Product Type Biologics
Status Completed
Recalling Firm Data Innovations, Inc.
City South Burlington
State VT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-02
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide.
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