Class 2 Device Recall Leica HistoCore PEGASUS

• Date Initiated by Firm: November 20, 2023
• Date Posted: December 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0590-2024
• Recall Event ID: 93467
• Product Classification: Processor, tissue, automated - Product Code IEO
• Product: Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
• Code Information: All devices with serial number: G0061-G0701
• FEI Number: 3002179321
• Recalling Firm/ Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH ; Heidelberger Str. 17-19; Nussloch Germany
• For Additional Information Contact: Margaret Walczak; 815-200-2717
• Manufacturer 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: 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.
• Quantity in Commerce: 98 devices
• Distribution: US, Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.