Home / Recalls / BD Biosciences, Systems & Reagents / Z-2397-2012

Z-2397-2012 Class II Terminated

Recalled by BD Biosciences, Systems & Reagents — San Jose, CA

Recall Details

Product Type
Devices
Report Date
September 26, 2012
Initiation Date
June 29, 2012
Termination Date
March 25, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96 kits

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.

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.

Code Information

Catalog number: 335775; Lot number 33412.

Other recalls by BD Biosciences, Systems & Reagents

  • Z-2090-2015 Class III — BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD F (June 15, 2015)
  • Z-1375-2015 Class II — CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent (March 23, 2015)
  • Z-1370-2015 Class II — BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics U (March 6, 2015)
  • Z-1000-2015 Class II — CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Sin (December 19, 2014)
  • Z-1002-2015 Class II — Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in (December 19, 2014)
  • Z-2233-2014 Class III — BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete pro (July 18, 2014)
  • Z-1977-2014 Class II — BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for (June 6, 2014)
  • Z-1536-2014 Class II — Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against huma (April 4, 2014)