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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 Kiestra Isolate Suspension Cuvettes Recalled for Barcode Errors

Agency Publication Date: November 7, 2025
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Summary

Becton Dickinson & Co. is recalling 29,760 units of the BD Kiestra Isolate Suspension Cuvette Array due to formatting errors in the 2D barcodes printed on the products. These errors prevent the analyzing system from correctly reading the expiration date, which causes the diagnostic instrument to enter an error state and makes the cuvettes unusable. The recall affects Catalog No. 246100 with specific lot numbers.

Risk

The barcode error prevents the diagnostic analyzing system from functioning correctly, which can lead to laboratory testing delays or the inability to process patient samples using the affected instrument.

What You Should Do

  1. This recall affects BD Kiestra Isolate Suspension Cuvette Arrays (Catalog No. 246100) identified by UDI-DI 30382902461006.
  2. Identify affected products by checking for lot numbers LM245590, LM245592, LM245593, LM245594, or LM245666 printed on the packaging.
  3. Stop using the recalled product immediately to prevent instrument errors and testing interruptions.
  4. Contact Becton Dickinson & Co. or your authorized distributor to arrange for a return, replacement, or correction of the affected cuvettes.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

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 Kiestra Isolate Suspension Cuvette Array
Model / REF:
246100
Lot Numbers:
LM245590
LM245592
LM245593
LM245594
LM245666
UDI:
30382902461006

The 2D barcodes contain formatting errors preventing the analyzing system from reading the expiration date.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97817
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Hospital supply distributors; Laboratory equipment suppliers
Manufactured In: United States
Units Affected: 29,760 units
Distributed To: Colorado, Connecticut, Kentucky, New Jersey, Tennessee, Texas, Utah

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.