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Recall Observatory FDA recall evidence

Device product

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

Z-0086-2021

August 31, 2020

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 86399
Status
Ongoing
Classification
Class II
Quantity
257 (US); 208 (ex-US)
Official record key
device-enforcement:Z-0086-2021

Official wording

Reason: 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

Code information: All units

Distribution pattern: Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Algeria, Argentina, Aruba, Australia, Bahrain, Bosnia-Herz., Brazil, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Malaysia, Martinque, Mexico, Monaco, Morocco, Namibia, New Caledonia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, S. Africa, S. Korea, Taiwan, Thailand, Ukraine, UAE, Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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