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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

Roche Diagnostics Operations, Inc.: Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

Agency Publication Date: October 8, 2020
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Affected Products

Product: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

All units

Product: DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

All units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86399
Status: Active
Manufacturer: Roche Diagnostics Operations, Inc.
Manufactured In: United States
Units Affected: 2 products (2623 (US); 3735 (ex-US); 257 (US); 208 (ex-US))

Were You Affected by This Recall?

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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 · 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.