FDA Device recall Z-1947-2024
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of Leica HistoCore PEGASUS Tissue Processor, REF 14048858005 by Leica Biosystems Nussloch, citing poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin ta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1947-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-10 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Leica Biosystems Nussloch |
| Distribution | US |
Product
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Reason
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Identifiers
| code_info | All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1947-2024%22
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