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 | Letter |
| 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 |
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