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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86399

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 31, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Roche Diagnostics Operations, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Z-0085-2021
Recall number
Z-0085-2021
Initiated
August 31, 2020
Classification
Class II
Status
Ongoing
Quantity
2623 (US); 3735 (ex-US)

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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

device · product 2 of 2

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

Z-0086-2021
Recall number
Z-0086-2021
Initiated
August 31, 2020
Classification
Class II
Status
Ongoing
Quantity
257 (US); 208 (ex-US)

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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