Summary
The FDA issued a Class II for Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) by LEICA BIOSYSTEMS NUSSLOCH GMBH. Reason: There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from a.
Details
Source
Device Recall
External ID
Z-0590-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Lot/Code Info: All devices with serial number: G0061-G0701
Quantity Affected: 98 devices
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.
Distribution
US, Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-20
Company
Nussloch, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LEICA BIOSYSTEMS NUSSLOCH GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LEICA BIOSYSTEMS NUSSLOCH GMBH have FDA actions?
LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0590-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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