🔍 RecallPedia

Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

Class I - Dangerous
🏥 Medical Devices Recalled: December 19, 2014 BD Biosciences, Systems & Reagents Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.
  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:
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

Product Codes/Lot Numbers:

Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1002-2015

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 →