Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949
  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:
Becton, Dickinson and Company, BD Biosciences
Reason for Recall:
False positive reaction on the reagent.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.

Product Codes/Lot Numbers:

Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1971-2020

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