Recall Z-0590-2024
Leica Biosystems Nussloch GmbH · initiated November 20, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Codes / lots: All devices with serial number: G0061-G0701
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.
FDA-determined cause: Other
Action taken
Leica issued an URGENT Medical Device Recall notice to its consignees on 11/20/2023 via email. The notice explained the issue with the device and instructed the consignee to ensure the selection of the correct setting of the carryover value for al created or edited protocols and follow the instructions in the IFU.
Details
- Recall number
- Z-0590-2024
- Initiated
- November 20, 2023
- Posted by FDA
- December 20, 2023
- Product code
- IEO – Processor, Tissue, Automated
- Quantity
- 98 devices
- Distribution
- US, Nationwide
- Recalling firm
- Leica Biosystems Nussloch GmbH, Nussloch