Leica HistoCore PEGASUS recall
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Why was Leica HistoCore PEGASUS recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All devices with serial number: G0061-G0701
- Product
- Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Quantity
- 98 devices
- Distribution
- US, Nationwide
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)