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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

Thermo Scientific Sensititre Mueller-Hinton Broth Recalled for Discoloration

Agency Publication Date: June 11, 2025
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Summary

Remel, Inc. is recalling 70 units of Thermo Scientific Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth with TES and Lysed Horse Blood (REF CP11410). The product may have an unusual color that can interfere with its performance in diagnostic laboratory testing. This recall affects lot number 226414. No injuries or diagnostic errors have been reported to date.

Risk

The broth may exhibit an off color that affects the accuracy of diagnostic performance. Using affected broth could lead to incorrect test results, which may result in improper medical treatment for patients.

What You Should Do

  1. This recall affects Thermo Scientific Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood (REF CP11410) with UDI/DI 848838018855 and lot number 226414.
  2. Stop using the recalled product immediately.
  3. Contact the manufacturer, Remel, Inc., or your authorized distributor to arrange for the return, replacement, or correction of the affected broth.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or 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: Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood
Model / REF:
CP11410
Lot Numbers:
226414
UDI:
848838018855

In vitro diagnostic device.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96810
Status: Active
Manufacturer: Remel, Inc
Sold By: authorized distributors; medical laboratories
Manufactured In: United States
Units Affected: 70 units
Distributed To: Alabama, Georgia, Kentucky, Virginia
Agency Last Updated: August 15, 2025

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.