Recall Z-2397-2012— BD Biosciences, Systems & Reagents

Name: FDA recall Z-2397-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-29

Class II · Terminated

Class II FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2012-06-29, terminated 2013-03-25. It names one FDA 510(k) clearance: K040026. 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..

Recalling firm: BD Biosciences, Systems & Reagents
Classification: Class II
Status: Terminated
Initiated: 2012-06-29
Terminated: 2013-03-25
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K040026 — BD FACS 7-COLOR SETUP BEADSBecton Dickinson Immunocytometry Systems·cleared 2004-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

Data sourced from openFDA. This site is unofficial and independent of the FDA.