The Recall Desk
SevereFDA (Devices)·Z-0086-2021·Announced 2020-10-14

Roche Discovery Ultra Staining System Recalled for Electrical Short Risk

Roche Diagnostics is recalling the DISCOVERY ULTRA Advanced Staining System due to fluid leaks that can cause electrical shorts, heat, and smoke.

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 burn injuries due to electrical shorts and melting components, which meets the criteria for a Severe rating involving significant injury or property damage reports.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only), Material Number 05987750001. The recall involves 257 units in the United States and 208 units outside the United States. The product is distributed nationwide and in numerous foreign countries.

The recall is 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.

Users of the DISCOVERY ULTRA Advanced Staining System should stop using the device and contact Roche Diagnostics Operations, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — Laboratory Equipment
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.

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Same hazard · fire

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