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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Class II Laboratory software, with a defect or glitch, was distributed. 1 B-2265-13