CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number: RD22/230/11
  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:
Cytocell Ltd.
Reason for Recall:
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

Product Codes/Lot Numbers:

Lot Number: RD22/230/11

Distribution:

Distributed in: TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0341-2023

Related Recalls

Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

Oct 27, 2022 Other Medical Devices View Details →