🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: June 29, 2012 BD Biosciences, Systems & Reagents Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog number: 335775; Lot number 33412.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BD Biosciences, Systems & Reagents
Reason for Recall:
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Catalog number: 335775; Lot number 33412.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2397-2012

Related Recalls

BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

BD Biosciences, Systems & Reagents

Class I - Dangerous

Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).

Jun 15, 2015 Diagnostic Equipment Nationwide View Details →