Enforcement Report - Week of September 26, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-2397-2012 |
| Classification | Class II |
| Code Info | Catalog number: 335775; Lot number 33412. |
| Product Distributed Qty | 96 kits |
| Reason For Recall | Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. |
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. |
-
