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U.S. Department of Health and Human Services

Class 2 Device Recall Leica HistoCore PEGASUS

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  Class 2 Device Recall Leica HistoCore PEGASUS see related information
Date Initiated by Firm November 20, 2023
Date Posted December 20, 2023
Recall Status1 Open3, 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
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 2		 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.
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