FDA Device recall Z-0590-2024
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) by Leica Biosystems Nussloch, citing there is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0590-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-20 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Leica Biosystems Nussloch |
| Distribution | US |
Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Reason
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.
Identifiers
| code_info | All devices with serial number: G0061-G0701 |
|---|
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-0590-2024%22
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