Leica HistoCore PEGASUS tissue processor recalled for tissue damage
LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. This is a voluntary precautionary recall due to a tissue processing defect caused by improper reagent levels; no actual diagnostic errors or patient harm have been reported.
Plain-English summary
LEICA BIOSYSTEMS NUSSLOCH GMBH is recalling 141 Leica HistoCore PEGASUS tissue processors due to a reagent filling defect. The affected devices are identified by serial numbers G0061-G0154, G0156-G0530, G0532-G0779, G0781, G0782 (UDI-DI 04049188216397).
When reagent levels exceed the maximum fill level marks on reagent bottles or in the paraffin tanks, the devices produce poorly processed and/or damaged biopsy tissue specimens. This processing defect can compromise the quality of tissue samples used for diagnosis.
The devices have been distributed worldwide, including throughout the United States and Canada, as well as to U.S. government facilities. Healthcare providers using affected equipment should contact LEICA BIOSYSTEMS NUSSLOCH GMBH for guidance on device inspection and repair or replacement.
The recalled product
- Product
- Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Affected units
- 141
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 (6)
- All devices with serial numbers: G0061 - G0154
- G0156 - G0530
- G0532 - G0779
- G0781
- G0782
- UDI-DI 04049188216397.
Distribution
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