The Recall Desk
HighFDA (Devices)·Z-0590-2024·Announced 2024-05-01

Tissue Processor Recall: HistoCore PEGASUS May Produce Damaged Specimens

Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product (damaged tissue specimens affecting diagnostic accuracy) with no reported illnesses or injuries, meeting the criteria for a High severity rating.

Plain-English summary

Leica Biosystems Nussloch GmbH is recalling 98 HistoCore PEGASUS automated tissue processors with serial numbers G0061 to G0701, distributed nationwide in the United States. The HistoCore PEGASUS is an automated instrument used in clinical and research laboratories to prepare biopsy tissue specimens for microscopic examination.

The recall is due to a protocol configuration error. An incorrect assignment of carryover values in created or edited protocols can result in tissue specimens being poorly processed or damaged. This impacts the quality of tissue preparation for diagnostic purposes.

Facilities and laboratories currently using HistoCore PEGASUS units with the affected serial numbers should be aware of this potential issue with their equipment.

The recalled product

Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Manufacturer
LEICA BIOSYSTEMS NUSSLOCH GMBH
Category
Medical Device — Histology Equipment
Hazard
  • tissue-damage
  • diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All devices with serial number: G0061-G0701

Distribution

Distributed nationwide across the United States.

Related recalls

Same category