Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0086-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 31, 2020

Date Posted: October 14, 2020

Recall Number: Z-0086-2021

Event ID: 86399

Reason for Recall:

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

Status: Ongoing

Product Quantity: 257 (US); 208 (ex-US)

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

Voluntary or Mandated:

Voluntary: Firm initiated