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.
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 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.
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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