BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US 349705 00382903497058 US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI 340914 00382903409143 OUS only 340915 00382903409150 OUS only 340916 00382903409167 OUS only
  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:
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Product Codes/Lot Numbers:

Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US 349705 00382903497058 US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI 340914 00382903409143 OUS only 340915 00382903409150 OUS only 340916 00382903409167 OUS only

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0562-2021

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