Paraffin Embedding Station Recalled for Internal Fire and Toxic Smoke Risk
The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with an actual hazard (toxic smoke and internal fire from sealing defect). Although no illnesses or injuries have been reported, the device poses a clear risk of harm to laboratory personnel. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' resulting in a High severity score.
Plain-English summary
Leica Biosystems Nussloch GmbH is recalling the Leica HistoCore Arcadia H paraffin embedding station. This device is used in laboratory histology settings for embedding tissue samples in paraffin. Two model numbers are affected: 14039354100 and 14039357258. Approximately 180 devices are included in this recall.
A defect has been identified in the paraffin tank sealing mechanism. This defect can cause toxic smoke generation and internal fire to develop within the device, creating a hazard for laboratory personnel who operate or work near the equipment.
The recalled devices have been distributed nationwide, including to government facilities. Anyone with an affected device should review the FDA recall notice for contact information and instructions from the manufacturer regarding remediation options.
The recalled product
- Product
- Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Hazard
- fire
- toxic-smoke
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 (20)
- Model/Catalog Number: 14039354100
- UDI-DI: 04049188194763
- Serial numbers: 58
- 62
- 98
- 99
- 101
- 117
- 120
- 121
- 122
- 123
- 124
- 125
- 127
- 128
- 129
- 177
- 178
- 179
Distribution
Distributed nationwide across the United States.
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