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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description 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.
Recall Number Z-1013-2013
Classification Class II
Code Info lot number: 540274420
Product Distributed Qty 4/20-card cartons
Reason For Recall The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

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.