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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62494
Product Type Devices
Status Ongoing
Recalling Firm BD Biosciences, Systems & Reagents
City San Jose
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-29
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention. Catalog number: 335775; Lot number 33412. Class II Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. 96 kits Z-2397-2012