The Recall Desk
SevereFDA (Devices)·Z-0085-2021·Announced 2020-10-14

Roche BenchMark ULTRA Advanced Staining System Recalled for Electrical Fire Risk

Roche Diagnostics is recalling BenchMark ULTRA Advanced Staining Systems due to a risk of fluid leaks causing electrical shorts, heat, and fire.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and burning due to electrical shorts, which constitutes a significant injury/property-damage risk under the rubric for Severe (Score 4).

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the BenchMark ULTRA Advanced Staining System (IVD), Material Number 05342716001. The recall involves 2,623 units in the United States and 3,735 units distributed internationally.

The recall is being issued because of a potential for fluid leaks within the instruments. These leaks can create an electrical short inside the power socket, which generates heat and smoke. This process can eventually lead to the burning and melting of the electrical cord connector and socket.

The affected units were distributed nationwide in the US and in numerous foreign countries, including Canada, the UK, and various nations in Europe, Asia, and the Americas. Users of these systems should stop using the product and contact the manufacturer for instructions on repair or replacement.

The recalled product

Product
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All units

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Roche Diagnostics Operations, Inc.

See all →

Same hazard · fire

See all →