FDA Device recall Z-2397-2012
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131
- FDA Device
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131 by Bd Biosciences Systems And Reagents, citing incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2397-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-29 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bd Biosciences Systems And Reagents |
| Distribution | US |
Product
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.
Reason
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Identifiers
| code_info | Catalog number: 335775; Lot number 33412. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2397-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.