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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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.
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