CLASS II ONGOING Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

Discovery Ultra Advanced Staining System recalled

Roche Diagnostics Operations is recalling Discovery Ultra Advanced Staining System (Ruo-Research Use Only) Material Number, distributed nationwide in the US. The recall was initiated on 31 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units

Quantity recalled257 (US); 208 (ex-US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0086-2021
FDA event ID: 86399
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Ongoing
Recall initiated: 31 Aug 2020
FDA classified: 8 Oct 2020
Reported: 14 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

31 Aug 2020	Recall initiated by company
8 Oct 2020	Classified by FDA	+38 days
14 Oct 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All units

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 86399

Reported	Class	Recall	Company	Reason	Where
14 Oct 2020	CLASS II	BenchMark Ultra Advanced Staining System recalled	Roche Diagnostics Operations	Packaging Defects	Nationwide

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