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Roche Diagnostics Operations, Inc. recalls DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

Recalled October 14, 2020 · FDA recall Z-0086-2021 · Roche Diagnostics Operations

Hazard
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 · FDA Class II
Units
257 (US); 208 (ex-US)
Sold at
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

Description

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

Product
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Manufacturer(s)
Roche Diagnostics Operations, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Roche Diagnostics Operations, Inc. recalls DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001 | RecallWatchUSA