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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64327
Product Type Devices
Status Completed
Recalling Firm Biomerieux Inc
City Hazelwood
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-06
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Distributed only in HI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. lot number: 540274420 Class II The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. 4/20-card cartons Z-1013-2013