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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Becton, Dickinson and Company, BD Biosciences: CD11b APC Diagnostic Staining Kits Recalled for Risk of Misdiagnosis

Agency Publication Date: January 5, 2024
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Summary

Becton, Dickinson and Company (BD Biosciences) has recalled 464 vials of CD11b APC, an in vitro diagnostic product used for cell staining in medical testing. The affected products may cause low or dim fluorescence signals, which can lead to false negative results or the misdiagnosis of blood-related cancers (hematological malignancies). This defect could result in delayed medical treatment or the need to collect additional samples from patients. Consumers should identify if they have the affected vials marked with specific reference numbers and expiration dates for 2025.

Risk

The product's failure to properly stain cells causes a weak fluorescence signal that diagnostic equipment may fail to detect. This mechanism can hide the presence of malignant cells, potentially leading a healthcare provider to incorrectly conclude a patient is healthy or delaying critical treatment for cancer.

What You Should Do

  1. Identify your product by checking the label for the following Reference (REF) and UDI-DI numbers: REF 340936 (UDI-DI 00382903409365) or REF 333143 (UDI-DI 00382903331437).
  2. Verify if the expiration date on the vial is 2025-02-28 (February 28, 2025).
  3. If your product matches these identifiers, immediately contact your healthcare provider or Becton, Dickinson and Company (BD Biosciences) to discuss the impact on previous test results and to obtain further instructions.
  4. Laboratory personnel should stop using the affected vials and contact the manufacturer regarding the return or replacement of the defective units.
  5. For additional information, contact Becton, Dickinson and Company at their San Jose facility or call the FDA's consumer line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CD11b APC: ASR (Vial)
Model / REF:
REF: 340936
UDI-DI: 00382903409365
Date Ranges: Expiration: 2025-02-28
Product: CD11b APC: CE (Vial)
Model / REF:
REF: 333143
UDI-DI: 00382903331437
Date Ranges: Expiration: 2025-02-28

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93569
Status: Active
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Sold By: Direct distribution to laboratories and healthcare facilities
Manufactured In: United States
Units Affected: 464 Vials
Distributed To: Illinois, Minnesota, Florida, Michigan, Maryland, North Carolina, New York, California, Georgia, Arkansas, Kansas, Pennsylvania, New Hampshire, Texas, Oklahoma, Massachusetts, Missouri, District of Columbia, Arizona, Indiana, New Jersey, Tennessee, Washington, Virginia, Connecticut

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.