LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Brand
LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany
Lot Codes / Batch Numbers
All devices with serial number: G0061-G0701
Products Sold
All devices with serial number: G0061-G0701
LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany is recalling Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) due to There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026