Stop using nowMedical device recall · FDA · Published August 31, 2020
Roche Discovery Ultra Advanced Staining System: Risk of electrical fire from leaks
Roche recalls all Discovery Ultra Advanced Staining Systems (RUO) due to potential fluid leaks causing electrical shorts, heat, smoke, and fire. No remedy specified in official notice.
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
“Roche Discovery Ultra Advanced Staining System: Risk of electrical fire from leaks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64402-roche-discovery-ultra-advanced-staining-system-risk-of-electrical-fire. Based on FDA recall #Z-0086-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled the DISCOVERY ULTRA Advanced Staining System on August 31, 2020, according to the FDA. The device poses a fire hazard due to potential fluid leaks that can cause electrical shorts and burning.
How to tell if you have it
Brand: Roche
Product: DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only)
Material Number: 05987750001
The hazard
Fluid leaks within the instruments can create an electrical short inside the power socket. This generates heat, smoke, and eventually causes burning and melting of the electrical cord connector and socket.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls since July 2, 2019. Recent similar recalls include a software defect in Roche cobas pro integrated solutions (Jan. 20, 2026), inconsistent results in the Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025), and erroneous test results from the Roche cobas HCYS Assay (Oct. 17, 2024). Other recent recalls of similar products include a risk of overheating in the FUJIFILM FDR Visionary Suite CH-200 X-ray Device (Jan. 9, 2026), a defective circuit board in the OXOS MC2 Portable X-Ray System (June 11, 2026), and an oil leak risk in the Philips Integris-Allura System (April 28, 2026).
How to tell if you have this one
The product is labeled as 'DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only)' with material number 05987750001. All units are affected, so no specific model or purchase date is needed.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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
Recall number
Product, codes & lots
Quantity
Z-0085-2021
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001; All units
2623 (US); 3735 (ex-US)
Z-0086-2021
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001; All units
257 (US); 208 (ex-US)
Based on the official FDA remedy
What to do — step by step
Stop using it now
Immediately stop using the Discovery Ultra Advanced Staining System (RUO) as it poses a fire risk due to potential fluid leaks.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0086-2021 (August 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0086-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.