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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
Recall Number Z-1422-2013
Classification Class II
Code Info PYR kit - lot 2276481 with expiration date 09/30/13
Product Distributed Qty 610 total test kits (PYR and Oxidase)
Reason For Recall In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

Event Detail

Event Id 65089
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Co.
City Sparks
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.