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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

BD FACS 7-Color Setup Beads Recalled Due to Instrument Setup Errors

Agency Publication Date: July 3, 2025
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Summary

BD Bio Sciences has recalled 868 units of BD FACS 7-Color Setup Beads used in laboratory flow cytometry. The recall was initiated due to errors in the spectral overlap factors table, which is used to calibrate instruments for fluorescence compensation. Using the affected beads can lead to inaccurate instrument setup before analyzing patient or research samples. The manufacturer has received customer complaints regarding data errors, though no physical injuries have been reported.

Risk

Incorrect instrument setup can lead to unreliable data analysis and inaccurate laboratory results. If fluorescence compensation is not set correctly, the instrument may misinterpret the samples being analyzed.

What You Should Do

  1. This recall affects BD FACS 7-Color Setup Beads (Ref 335775 and 666289) used for fluorescence compensation in flow cytometry instruments.
  2. Check your laboratory inventory for Lot numbers 85612, 85613, 85637, or 85638. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact BD Bio Sciences or your authorized distributor to arrange for a return, replacement, or correction of the affected kits.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD FACS 7-Color Setup Beads (25 setups per kit)
Variants: Rx Only, IVD
Model / REF:
335775
Lot Numbers:
85612
85613
UDI:
382903357758

Used in flow cytometry for fluorescence compensation.

Product: BD FACS 7-Color Setup Beads (25 Runs)
Variants: CE, IVD
Model / REF:
666289
Lot Numbers:
85637
85638
UDI:
382906662897

Used in flow cytometry for fluorescence compensation.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96922
Status: Active
Manufacturer: Becton, Dickinson and Company, BD Bio Sciences
Sold By: BD Bio Sciences authorized distributors
Manufactured In: United States
Units Affected: 2 products (590 units; 278 units)
Distributed To: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia

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.