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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. PYR kit - lot 2276481 with expiration date 09/30/13 Class II In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. 610 total test kits (PYR and Oxidase) Z-1422-2013
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria. Oxidase kit - lot 2222008 with expiration date 08/31/13 Class II In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. 610 total test kits (PYR and Oxidase) Z-1423-2013
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