Z-0590-2024 Class II Ongoing
FDA device recall Z-0590-2024 was initiated by LEICA BIOSYSTEMS NUSSLOCH GMBH on November 20, 2023 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 98 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- November 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 devices
Product Description
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Reason for Recall
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.
Distribution Pattern
US, Nationwide
Code Information
All devices with serial number: G0061-G0701